Teftec Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Teftec Corp.” (first 1996, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | 8 | 8 |
Review panels
Most recent Teftec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022652 | ALPHATRAC, MODEL A 205 | ITI | 2002-11-21 | 104 |
| K013307 | OMEGATRAC, MODEL Z105 | ITI | 2002-02-08 | 127 |
| K993160 | OMEGA TRAC, MODEL Z100 | ITI | 1999-11-18 | 58 |
| K992628 | FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 | ITI | 1999-10-25 | 81 |
| K992627 | FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500 | ITI | 1999-10-25 | 81 |
| K983066 | FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 | ITI | 1998-11-27 | 86 |
| K982815 | ALPHATRAC, MODEL A200 | ITI | 1998-11-06 | 87 |
| K955240 | OMEGATRAC BY TEFTEC | ITI | 1996-07-01 | 230 |
Recalls
openFDA lists no recalls under a recalling firm named Teftec 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 Teftec Corp.?
FDA lists 8 510(k) clearances under the applicant name “Teftec Corp.” (first 1996, latest 2002), across 1 product code 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 Teftec Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teftec Corp. is 86 days.
Which FDA product codes appear under Teftec Corp.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 8).
Next steps
- See all 8 Teftec Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Teftec 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 (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.