Cryomedics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cryomedics, Inc.” (first 1980, latest 1985), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 95 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| HEX | Colposcope (And Colpomicroscope) | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
Review panels
Most recent Cryomedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851152 | MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR | DWS | 1985-06-24 | 95 |
| K844431 | YN CO2 LASER SYSTEM 30W | HHR | 1985-02-25 | 101 |
| K842888 | DUAL CHANNEL TENS, PULSAR REMOTE CONTRL | GZJ | 1985-01-14 | 175 |
| K842959 | MC-4000 CONSOLE & PROBES | GEH | 1984-12-07 | 133 |
| K842704 | MT-700 MT-750 FT-350 | GEH | 1984-08-01 | 21 |
| K801730 | KRYMED SYSTEM 4001 TILT SCOPE | HEX | 1980-08-13 | 19 |
| K800335 | KRYMED LIQUID NITROGEN CRYOJET | GEH | 1980-04-04 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Cryomedics, 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 Cryomedics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cryomedics, Inc.” (first 1980, latest 1985), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cryomedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryomedics, Inc. is 95 days.
Which FDA product codes appear under Cryomedics, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 3); DWS (Instruments, Surgical, Cardiovascular, 1); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1).
Next steps
- See all 7 Cryomedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Cryomedics, 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.