Xomed-Treace, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Xomed-Treace, Inc.” (first 1991, latest 1995), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 263 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 | 3 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | 2 |
| ETN | Stimulator, Nerve | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 1 |
| ERA | Otoscope | 1 | 1 |
| ETD | Tube, Tympanostomy | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
Review panels
- Ear, Nose and Throat (10)
- Anesthesiology (1)
- General Hospital (1)
Most recent Xomed-Treace, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940028 | ENDOSCOPE SHEATH | EOB | 1995-03-24 | 445 |
| K941407 | TYMPANOSTOMY (VENTILATION) TUBE | ETD | 1995-03-14 | 356 |
| K945659 | BLACKSTAR(TM) STAR SYSTEM | ERL | 1995-01-09 | 53 |
| K932771 | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | EQH | 1994-08-24 | 442 |
| K933672 | XOMED-TREACE SCOPESHEATH | EOB | 1994-07-18 | 355 |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | ETN | 1994-05-13 | 245 |
| K933105 | XOMED-TREACE RIGID ROD LENS ENDOSCOPE | EOB | 1994-01-05 | 194 |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | ETN | 1993-08-17 | 281 |
| K922880 | XOMED TREACE JET VENTILATION TUBE | BTR | 1993-04-15 | 304 |
| K923830 | XOMED-TREACE ALPHASCOPE | ERA | 1992-11-09 | 101 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Xomed-Treace, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Xomed, Inc. (82 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xomed-Treace, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Xomed-Treace, Inc.” (first 1991, latest 1995), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xomed-Treace, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xomed-Treace, Inc. is 263 days.
Which FDA product codes appear under Xomed-Treace, Inc.?
The most frequent FDA product codes under this applicant name are EOB (Nasopharyngoscope (Flexible Or Rigid), 3); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 2); ETN (Stimulator, Nerve, 2).
Next steps
- See all 12 Xomed-Treace, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOB, Xomed-Treace, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.