Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tiara Medical Systems, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
177 daysmedian FDA review time
318 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051583 | TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MO | Tiara Medical Systems, Inc. | 2005-11-04 | 142 | 0 |
| K043382 | TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830 | Tiara Medical Systems, Inc. | 2005-01-19 | 41 | 0 |
| K034053 | TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS | Tiara Medical Systems, Inc. | 2004-06-24 | 177 | 0 |
| K031935 | TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-25 | Tiara Medical Systems, Inc. | 2004-03-03 | 254 | 0 |
| K012207 | ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, | Tiara Medical Systems, Inc. | 2001-07-23 | 7 | 0 |
| K992192 | AIRPILOTMASK, MODEL TMS-900 | Tiara Medical Systems, Inc. | 2000-05-12 | 318 | 0 |
| K964092 | TMS COMFORT SERIES NASAL CPAP MASK | Tiara Medical Systems, Inc. | 1997-07-31 | 293 | 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