Cardiogenes: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Cardiogenes” (first 1992, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 20 | 20 |
Review panels
Most recent Cardiogenes 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961560 | ECLIPSE 2000 | GEX | 1997-01-27 | 291 |
| K955006 | ECLIPSE 2100 | GEX | 1996-01-17 | 77 |
| K952755 | POWERSCULPTOR PROBES | GEX | 1995-09-14 | 91 |
| K953658 | CORSSFIRE PLUS | GEX | 1995-08-21 | 67 |
| K953424 | ECLIPSE 3200 | GEX | 1995-08-11 | 39 |
| K945126 | ECLIPSE 3200 | GEX | 1995-01-18 | 91 |
| K944758 | SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT | GEX | 1994-12-27 | 95 |
| K944153 | ECLIPSE 3200 | GEX | 1994-11-09 | 90 |
| K944151 | OPTICAL FIBER FOR ENT APPLICATIONS | GEX | 1994-11-01 | 84 |
| K943171 | CROSSFIRE(TM) (705-10650) | GEX | 1994-09-20 | 96 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiogenes.
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 Cardiogenes?
FDA lists 20 510(k) clearances under the applicant name “Cardiogenes” (first 1992, latest 1997), 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 Cardiogenes?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiogenes is 94 days.
Which FDA product codes appear under Cardiogenes?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 20).
Next steps
- See all 20 Cardiogenes clearances with predicates and recalls
- Run predicate analysis for product code GEX, Cardiogenes'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.