Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OHP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
160 daysmedian FDA review time
246 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | 2020-02-21 | 239 | 0 |
| K180619 | Bongo | Innomed Healthscience, Inc. | 2018-08-16 | 160 | 0 |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVE | Ventus Medical, Inc. | 2010-12-02 | 100 | 0 |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | Ventus Medical, Inc. | 2009-04-03 | 45 | 1 |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | Ventus Medical, Inc. | 2008-02-08 | 246 | 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