Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cryoconcepts LP — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

113 daysmedian FDA review time
430 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251493Skin Clinic Freeze Point for Warts and Skin TagsCryoconcepts LP2025-05-2270
K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025-04-152020
K242625Freeze Point & Private Label VersionsCryoconcepts LP2024-10-25520
K240106Histofreezer VCryoconcepts LP2024-06-101460
K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP2022-06-174300
K190407CryoLabCryoconcepts LP2019-04-22600
K183601CryoTouchCryoconcepts LP2019-04-181130
K172769CryOmega FlexxCryoconcepts LP2017-11-30780

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