Cryoconcepts LP: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cryoconcepts LP” (first 2017, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 96 days. Since 2017 the median was 96 days, against 88 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 1 | 78 |
| 2018 | 0 | — |
| 2019 | 2 | 86 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 430 |
| 2023 | 0 | — |
| 2024 | 2 | 99 |
| 2025 | 2 | 104 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cryoconcepts LP took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 8 | 8 |
Review panels
Most recent Cryoconcepts LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | GEH | 2025-05-22 | 7 |
| K242932 | Skin Clinic Nitro Clear Wart Remover | GEH | 2025-04-15 | 202 |
| K242625 | Freeze Point & Private Label Versions | GEH | 2024-10-25 | 52 |
| K240106 | Histofreezer V | GEH | 2024-06-10 | 146 |
| K211099 | Freezen Clear Skin Clinic Warts & Tags | GEH | 2022-06-17 | 430 |
| K190407 | CryoLab | GEH | 2019-04-22 | 60 |
| K183601 | CryoTouch | GEH | 2019-04-18 | 113 |
| K172769 | CryOmega Flexx | GEH | 2017-11-30 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Cryoconcepts LP.
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 Cryoconcepts LP?
FDA lists 8 510(k) clearances under the applicant name “Cryoconcepts LP” (first 2017, latest 2025), 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 Cryoconcepts LP?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cryoconcepts LP is 96 days. Since 2017: 96 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cryoconcepts LP?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 8).
Next steps
- See all 8 Cryoconcepts LP clearances with predicates and recalls
- Run predicate analysis for product code GEH, Cryoconcepts LP'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.