Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryosurgery, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
191 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-10-16 | 28 | 0 |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | 2025-10-10 | 29 | 0 |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-03-13 | 125 | 0 |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | 2024-12-03 | 26 | 0 |
| K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | 2023-12-04 | 66 | 0 |
| K982506 | VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM | Cryosurgery, Inc. | 1999-01-27 | 191 | 0 |
| K955083 | VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) | Cryosurgery, Inc. | 1996-02-08 | 136 | 0 |
| K944221 | VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED | Cryosurgery, Inc. | 1994-12-15 | 122 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda