Cruxi
FDA record research
The 2021–2025 analysis contains 1 selected substantially-equivalent FDA decisions under primary product code PLC. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 2 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-08-25. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 1 decisions; the separate all-observed-date count is 10. 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.
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. (a) Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices. (b) Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.” [67 FR 68512, Nov. 12, 2002]
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 1 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
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.
10 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
2 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 |
|---|---|---|---|---|
| K254304 ↗iNOS intraoral biosensor | Achaemenid, LLC | 2026-08-25 | Traditional | 237 |
| K252765 ↗ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026-04-06 | Traditional | 220 |
| K233497 ↗Rest Assure System | Somnomed, Inc. | 2024-10-03 | Traditional | 338 |
| K190353 ↗Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | 2020-04-10 | Traditional | 420 |
| K181571 ↗OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | 2019-04-19 | Traditional | 309 |
| K172859 ↗Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | 2017-11-22 | Traditional | 63 |
| K170606 ↗Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab | 2017-11-16 | Traditional | 260 |
| K161624 ↗MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016-11-07 | Traditional | 147 |
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 | PLC [1] |
| Generic device category | Sleep Appliances With Patient Monitoring [1] |
| Recorded scope | For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy. [1] |
| Recorded class | 2 [1] |
| Regulation | 872.5570 [1] |
| Medical specialty | Dental [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 11:23:00 GMT · retrieved 2026-10-06
Source key D02 · snapshot ebbd8a247f70a83dc877882bfbe034d8a4a7fa26e4f9ea116087cd8a1c909ff0
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Mon, 04 May 2026 20:48:00 GMT · retrieved 2026-10-07
Source key D02 · snapshot d843eb7d558a29d5aadf06b9c5029eeedbae00dfe65a39c7a4a42adeb6a761a5
Fri, 04 Oct 2024 19:10:04 GMT · retrieved 2026-10-07
Source key D02 · snapshot fad326aa19f6781ad2cf4e5a2a479f632357878f7d6e8e1287db334fdde98332
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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