Cytocare, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cytocare, Inc.” (first 1992, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
Review panels
Most recent Cytocare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954321 | ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) | GEI | 1995-10-13 | 30 |
| K952698 | ENDOCARE ELECTROSURGICAL HANDPIECE | GEI | 1995-08-14 | 62 |
| K952587 | ENDOCARE MONOPOLAR ELECTRODES | GEI | 1995-07-17 | 42 |
| K942299 | ENDOCARE CRYOTHERAPY SYSTEM | GEH | 1995-01-19 | 252 |
| K945054 | ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM | GEX | 1994-11-28 | 45 |
| K934211 | CYTOCARE DIODE LASER SYSTEM | GEX | 1994-05-17 | 260 |
| K921708 | CYTOCARE LASER CATHETER FOR UROLOGY | GEX | 1992-10-01 | 174 |
Recalls
openFDA lists no recalls under a recalling firm named Cytocare, 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 Cytocare, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cytocare, Inc.” (first 1992, latest 1995), across 3 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 Cytocare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cytocare, Inc. is 62 days.
Which FDA product codes appear under Cytocare, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); GEX (Powered Laser Surgical Instrument, 3); GEH (Unit, Cryosurgical, Accessories, 1).
Next steps
- See all 7 Cytocare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Cytocare, 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 (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.