Treace Medical, Inc.: FDA clearances and approvals
Treace Medical, Inc. has 80 FDA 510(k) clearances (first 1982, latest 1989), across 41 product codes in 7 review panels. Median 510(k) review time: 31 days.
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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | 9 | 9 |
| ETB | Prosthesis, Partial Ossicular Replacement | 6 | 6 |
| EQH | Source, Carrier, Fiberoptic Light | 4 | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| EPY | Speculum, Ent | 2 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | 2 |
| JYG | Curette, Ear | 2 | 2 |
| JYM | Inserter, Myringotomy Tube | 2 | 2 |
| KAE | Forceps, Ent | 2 | 2 |
Plus 31 more product codes.
Review panels
- Ear, Nose and Throat (47)
- General and Plastic Surgery (12)
- General Hospital (4)
- Dental (3)
- Anesthesiology (1)
- Ophthalmic (1)
- Radiology (1)
Most recent Treace Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883727 | BUCKET PROSTHESIS PORP | ETB | 1989-01-13 | 135 |
| K882349 | MALLET, SURGICAL | HXL | 1988-06-23 | 16 |
| K874779 | BIPOLATOR 50 | GEI | 1988-01-29 | 71 |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | ERL | 1987-09-04 | 24 |
| K872000 | EYE GARD | HOY | 1987-07-21 | 56 |
| K870765 | CANNULATED INSTRUMENT CLEANERS | EKW | 1987-05-27 | 90 |
| K871706 | OPTHA PREP | HMT | 1987-05-18 | 17 |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | LRJ | 1987-05-07 | 70 |
| K870766 | PROSTHESIS WIRE | ETB | 1987-04-15 | 48 |
| K870764 | SCHUKNECHT WIRE CUTTING SCISSORS | — | 1987-03-18 | 20 |
70 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Treace Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Treace Medical, Inc. have?
Treace Medical, Inc. has 80 FDA 510(k) clearances (first 1982, latest 1989), across 41 product codes in 7 review panels.
How long does FDA take to clear Treace Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Treace Medical, Inc.'s cleared 510(k)s is 31 days.
What devices does Treace Medical, Inc. make?
Its most frequent FDA product codes are ETD (Tube, Tympanostomy, 9); ETB (Prosthesis, Partial Ossicular Replacement, 6); EQH (Source, Carrier, Fiberoptic Light, 4).
Has Treace Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Treace Medical, Inc. Related entities may recall under other names.
Next steps
- See all 80 Treace Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETD, Treace Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.