Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Preceptis Medical · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151830 | Hummingbird Tympanostomy Tube | Preceptis Medical | 2015-09-21 | 77 | 0 |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | Preceptis Medical | 2015-04-23 | 251 | 0 |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | Preceptis Medical | 2014-08-22 | 242 | 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