Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PLC — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
220 daysmedian FDA review time
420 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026-04-06 | 220 | 0 |
| K233497 | Rest Assure System | Somnomed, Inc. | 2024-10-03 | 338 | 0 |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Eng | Residential Home Sleep Services | 2020-04-10 | 420 | 0 |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitr | Mark Abramson, D.D.S., Inc. | 2019-04-19 | 309 | 0 |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sle | Prosomnous Sleep Technologies | 2017-11-22 | 63 | 0 |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab | 2017-11-16 | 260 | 0 |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016-11-07 | 147 | 0 |
| K160239 | TAP 3, TAP 1 | Airway Management, Inc. | 2016-08-10 | 191 | 0 |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent F | Somnomed, Inc. | 2015-06-18 | 125 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda