Cryodyne Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cryodyne Technologies, Inc.” (first 1986, latest 1993), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| BXK | Gas, Calibration (Specified Concentration) | 1 | 1 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
| KEJ | Stages, Microscope | 1 | 1 |
| KJB | Apparatus, Roller | 1 | 1 |
| KSP | Apparatus, Cell-Freezing And Reagents | 1 | 1 |
Review panels
- Anesthesiology (2)
- Pathology (2)
- Hematology (1)
- General and Plastic Surgery (1)
Most recent Cryodyne Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926464 | L.C.S.3000 | GEH | 1993-08-24 | 243 |
| K932520 | CALIBRATION GAS | BXK | 1993-08-19 | 86 |
| K881465 | CRYOBIOLOGICAL FREEZER | KSP | 1988-04-21 | 15 |
| K881467 | MICROSCOPE STAGE HEATER | KEJ | 1988-04-18 | 12 |
| K881466 | CELL-CULTURE SHAKER | KJB | 1988-04-18 | 12 |
| K860738 | CTC 30, 40, 1 LIQUID OXYGEN LITERS | BYJ | 1986-08-06 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Cryodyne Technologies, 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 Cryodyne Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Cryodyne Technologies, Inc.” (first 1986, latest 1993), across 6 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 Cryodyne Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryodyne Technologies, Inc. is 50 days.
Which FDA product codes appear under Cryodyne Technologies, Inc.?
The most frequent FDA product codes under this applicant name are BXK (Gas, Calibration (Specified Concentration), 1); BYJ (Unit, Liquid-Oxygen, Portable, 1); GEH (Unit, Cryosurgical, Accessories, 1).
Next steps
- See all 6 Cryodyne Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXK, Cryodyne Technologies, 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.