Key Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Key Surgical, Inc.” (first 1989, latest 2015), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 | 2 | 110 |
| 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
| MAW | Marker, Suture Identification | 1 | 1 |
Review panels
Most recent Key Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | FTA | 2015-09-22 | 204 |
| K151222 | Cautery Tip Cleaner | GEI | 2015-05-22 | 15 |
| K910328 | KEY COMFORT GRIPS | FSM | 1991-03-06 | 40 |
| K896676 | KEY VASCULAR LOOPS | KDC | 1990-02-27 | 92 |
| K896472 | KEY VASCULAR BOOTIES | MAW | 1989-12-14 | 31 |
| K895591 | SILICONE INSTRUMENT SHODS | GDJ | 1989-10-20 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Key Surgical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Key Surgical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Key Surgical, Inc.” (first 1989, latest 2015), across 6 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 Key Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Key Surgical, Inc. is 38 days.
Which FDA product codes appear under Key Surgical, Inc.?
The most frequent FDA product codes under this applicant name are FSM (Tray, Surgical, Instrument, 1); FTA (Light, Surgical, Accessories, 1); GDJ (Clamp, Surgical, General & Plastic Surgery, 1).
Next steps
- See all 6 Key Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FSM, Key Surgical, 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, 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.