Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KMA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140542 | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | Rhinosystems, Inc. | 2014-06-27 | 115 | 0 |
| K973875 | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | Respironics, Inc. | 1998-01-26 | 108 | 0 |
| K963550 | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | Respironics, Inc. | 1996-11-01 | 57 | 0 |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | 1995-06-21 | 162 | 0 |
| K822351 | POWDER BLOWERS | Kelleher Corp. | 1982-09-14 | 39 | 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