Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xomed-Treace, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
281 daysmedian FDA review time
442 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940028 | ENDOSCOPE SHEATH | Xomed-Treace, Inc. | 1995-03-24 | 445 | 0 |
| K941407 | TYMPANOSTOMY (VENTILATION) TUBE | Xomed-Treace, Inc. | 1995-03-14 | 356 | 0 |
| K945659 | BLACKSTAR(TM) STAR SYSTEM | Xomed-Treace, Inc. | 1995-01-09 | 53 | 0 |
| K932771 | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | Xomed-Treace, Inc. | 1994-08-24 | 442 | 0 |
| K933672 | XOMED-TREACE SCOPESHEATH | Xomed-Treace, Inc. | 1994-07-18 | 355 | 0 |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | Xomed-Treace, Inc. | 1994-05-13 | 245 | 0 |
| K933105 | XOMED-TREACE RIGID ROD LENS ENDOSCOPE | Xomed-Treace, Inc. | 1994-01-05 | 194 | 0 |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Xomed-Treace, Inc. | 1993-08-17 | 281 | 2 |
| K922880 | XOMED TREACE JET VENTILATION TUBE | Xomed-Treace, Inc. | 1993-04-15 | 304 | 0 |
| K923830 | XOMED-TREACE ALPHASCOPE | Xomed-Treace, Inc. | 1992-11-09 | 101 | 0 |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Xomed-Treace, Inc. | 1991-09-23 | 91 | 0 |
| K905800 | X-T AIR DRILL | Xomed-Treace, Inc. | 1991-04-22 | 115 | 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