Cruxi
FDA record research
The 2021–2025 analysis contains 24 selected substantially-equivalent FDA decisions under primary product code FED. 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 2026-09-21. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 24 decisions; the separate all-observed-date count is 105. These denominators describe different date ranges.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
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.
The middle 50% of the 24 valid date pairs spans 81.8–149.0 calendar days. This describes selected recorded submissions, including elapsed time outside active FDA review. It is not an FDA review-time measure or a delivery promise.
| Recorded type | Decisions | Valid date pairs | Median calendar days | Middle 50% |
|---|---|---|---|---|
| Special | 4 | 4 | Withheld: n < 20 | — |
| Traditional | 20 | 20 | 126.0 | 103.0–183.8 |
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.
105 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 10 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 |
|---|---|---|---|---|
| K260512 ↗Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-09-21 | Traditional | 216 |
| K262262 ↗Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2026-09-18 | Traditional | 78 |
| K260410 ↗Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-09-11 | Special | 214 |
| K261915 ↗Navigator Flex Ureteral Access Sheath Set | Boston Scientific Corporation | 2026-08-04 | Traditional | 56 |
| K260965 ↗CVAC Aspiration System | Calyxo, Inc. | 2026-04-13 | Special | 21 |
| K260521 ↗ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. | 2026-04-06 | Traditional | 48 |
| K252572 ↗Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 2025-10-07 | Traditional | 54 |
| K250128 ↗Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | 2025-09-19 | Traditional | 245 |
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 | FED [1] |
| Generic device category | Endoscopic Access Overtube, Gastroenterology-Urology [1] |
| Recorded scope | To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation. [1] |
| Recorded class | 2 [1] |
| Regulation | 876.1500 [1] |
| Medical specialty | Gastroenterology, Urology [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.
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.
Use the 2021–2025 cohort, and compare the recorded submission type before discussing calendar elapsed time. Separate your own preparation work from the recorded receipt-to-decision period.
Useful evidence: Chosen K numbers, submission types, dates and your own document/test readiness.
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, 02 Oct 2026 17:40:06 GMT · retrieved 2026-10-07
Source key D02 · snapshot 682376a95fba482b1ae0efe245ea7f5b80788b49b54730e12b9fc09ed11c0cb3
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Fri, 02 Oct 2026 17:08:35 GMT · retrieved 2026-10-07
Source key D02 · snapshot 45f17ceab8fad6adccc46a16e93385eaba9fd68e19e5eddb965ce21fa5b03030
Fri, 04 Sep 2026 11:29:52 GMT · retrieved 2026-10-07
Source key D02 · snapshot 6cadf8a011e11b34ce7adde835d6b50f9ed85c545696a44df26367969c906585
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
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