Trebay Medical Corp.: FDA clearances and approvals
Trebay Medical Corp. has 14 FDA 510(k) clearances (first 1995, latest 1996), across 8 product codes in 1 review panel. Median 510(k) review time: 32 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 |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | 5 | 5 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | 2 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 1 | 1 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Review panels
- Ear, Nose and Throat (14)
Most recent Trebay Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955704 | TREBAY MICRODEBRIDER SYSTEM | EQJ | 1996-01-30 | 46 |
| K955560 | TREBAY SCOPE IRRIGATED CLEARING SLEEVE | EOB | 1995-12-22 | 16 |
| K955294 | SOF - ABRASION BUR | EQJ | 1995-12-22 | 35 |
| K955447 | TYMPANOSTOMY TUBE | ETD | 1995-12-21 | 22 |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | EQJ | 1995-12-06 | 44 |
| K954795 | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES | ETD | 1995-11-15 | 28 |
| K954796 | MICRO-INGRESSOR HANDIPIECE | ERL | 1995-11-06 | 19 |
| K954715 | MICRO-PLANER HANDPIECE | ERL | 1995-10-27 | 15 |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | ETA | 1995-10-27 | 29 |
| K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT | ETB | 1995-10-27 | 29 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Trebay Medical Corp..
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 Trebay Medical Corp. have?
Trebay Medical Corp. has 14 FDA 510(k) clearances (first 1995, latest 1996), across 8 product codes in 1 review panel.
How long does FDA take to clear Trebay Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Trebay Medical Corp.'s cleared 510(k)s is 32 days.
What devices does Trebay Medical Corp. make?
Its most frequent FDA product codes are EQJ (Bur, Ear, Nose And Throat, 5); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 2); ETD (Tube, Tympanostomy, 2).
Has Trebay Medical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Trebay Medical Corp. Related entities may recall under other names.
Next steps
- See all 14 Trebay Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code EQJ, Trebay Medical Corp.'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.