Dynatech Cryomedical Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dynatech Cryomedical Co.” (first 1976, latest 1977), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 11 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 |
|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | 3 | 3 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 1 | 1 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 1 | 1 |
| GKJ | Spinner, Slide, Automated | 1 | 1 |
Review panels
Most recent Dynatech Cryomedical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771898 | AUTOMATED SLIDE SPINNER | GKJ | 1977-10-18 | 12 |
| K771815 | SIGMOSCOPE | FAM | 1977-10-07 | 10 |
| K770896 | COLPOSCOPE MODEL II | HEX | 1977-06-03 | 18 |
| K770614 | MONITOR, GAS MANIFOLD | BXH | 1977-04-07 | 7 |
| K761205 | DYNATECH JD7/JD7P COLPOSCOPE | HEX | 1976-12-17 | 10 |
| K760763 | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I | HEX | 1976-10-20 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Dynatech Cryomedical Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dynatech Laboratories, Inc. (44 510(k)s)
- Dynatech Corp. (27 510(k)s)
- Dynatech Medical Products (5 510(k)s)
- Dynatech Research & Development Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dynatech Cryomedical Co.?
FDA lists 6 510(k) clearances under the applicant name “Dynatech Cryomedical Co.” (first 1976, latest 1977), across 4 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 Dynatech Cryomedical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynatech Cryomedical Co. is 11 days.
Which FDA product codes appear under Dynatech Cryomedical Co.?
The most frequent FDA product codes under this applicant name are HEX (Colposcope (And Colpomicroscope), 3); BXH (Gauge, Gas Pressure, Cylinder/Pipeline, 1); FAM (Sigmoidoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 6 Dynatech Cryomedical Co. clearances with predicates and recalls
- Run predicate analysis for product code HEX, Dynatech Cryomedical Co.'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.