Cruxi
FDA record research
The 2021–2025 analysis contains 19 selected substantially-equivalent FDA decisions under primary product code LOX. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 6 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-08-14. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 19 decisions; the separate all-observed-date count is 88. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. (a) Standard PTCA Catheter —(1) Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. (2) Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document. (b) Cutting/scoring PTCA Catheter —(1) Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis. (2) Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3. [75 FR 54496, Sept. 8, 2010]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Historical FDA comparison
All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.
There are 19 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
| Recorded type | Decisions | Valid date pairs | Median calendar days | Middle 50% |
|---|---|---|---|---|
| Special | 4 | 4 | Withheld: n < 20 | — |
| Traditional | 15 | 15 | Withheld: n < 20 | — |
Different submission types and evidence packages are not interchangeable. These selected records do not establish that a particular route is available for your product.
Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).
Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.
88 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.
Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.
Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.
Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.
Separate partial-year update
6 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 0 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.
| Official record / device | Recorded applicant | Decision | Recorded type | Calendar days |
|---|---|---|---|---|
| K261428 ↗NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | 2026-08-14 | Traditional | 106 |
| K261759 ↗Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | 2026-07-27 | Traditional | 60 |
| K252116 ↗Firefighter Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 | Traditional | 274 |
| K254022 ↗FLASH Flex Aorto-Ostial Angioplasty System | Verge Medical, Inc. | 2026-04-02 | Traditional | 107 |
| K252295 ↗Ryurei | Terumo Corporation | 2026-03-27 | Traditional | 247 |
| K251970 ↗Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | 2026-01-17 | Traditional | 205 |
| K242969 ↗Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024-10-25 | Special | 29 |
| K233499 ↗Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 | Traditional | 290 |
Supporting documents actually acquired
Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.
The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.
Known context: US. Match the intended use and design with the recorded category before treating it as applicable.
| Source fact | Recorded value |
|---|---|
| FDA product code | LOX [1] |
| Generic device category | Catheters, Transluminal Coronary Angioplasty, Percutaneous [1] |
| Recorded scope | A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. [1] |
| Recorded class | 2 [1] |
| Regulation | 870.5100 [1] |
| Medical specialty | Cardiovascular [1] |
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
This recent cohort has fewer than 20 valid date pairs, so it supplies no median or percentile benchmark. Ask for a schedule based on actual preparation, evidence gaps, interactions and response assumptions; keep any historical decision context separately dated.
Useful evidence: Document/test readiness, unresolved route/evidence tasks and the assumptions behind the specialist’s proposed sequence.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
Fri, 04 Sep 2026 11:27:32 GMT · retrieved 2026-10-06
Source key D02 · snapshot 4aba9e1e981e1f804be8f3cba91d4f69a89910753a9986b4f996ca47357719b0
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Fri, 07 Aug 2026 21:39:49 GMT · retrieved 2026-10-07
Source key D02 · snapshot 1243daa23c716c7212978b739980cfb789d38ef4a09a8f4dc00a83da636b1cc7
Mon, 04 May 2026 20:39:31 GMT · retrieved 2026-10-07
Source key D02 · snapshot 4b66b9774f5c93d8549157ee39d57d2c75af1e702fbd54627649ff910388c870
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
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