Trebay Medical Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Trebay Medical Corp.” (first 1995, latest 1996), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 32 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Trebay Medical Corp.?
FDA lists 14 510(k) clearances under the applicant name “Trebay Medical Corp.” (first 1995, latest 1996), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trebay Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trebay Medical Corp. is 32 days.
Which FDA product codes appear under Trebay Medical Corp.?
The most frequent FDA product codes under this applicant name are EQJ (Bur, Ear, Nose And Throat, 5); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 2); ETD (Tube, Tympanostomy, 2).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.