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

Cryomedical Sciences, Inc. — Predicate Candidate Screening

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

135 daysmedian FDA review time
193 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011073CRYOPLAN SYSTEMCryomedical Sciences, Inc.2001-08-221350
K982055ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850Cryomedical Sciences, Inc.1998-09-08890
K980668CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 79Cryomedical Sciences, Inc.1998-07-171470
K980670CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 7Cryomedical Sciences, Inc.1998-07-171470
K973190ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIECryomedical Sciences, Inc.1997-11-21880
K970995CMS CRYOLITECryomedical Sciences, Inc.1997-07-071100
K964336CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc.1997-03-201400
K953637CMS ACCUPROBE 550/530Cryomedical Sciences, Inc.1995-12-041240
K952895CMS URETHRAL WARMERCryomedical Sciences, Inc.1995-10-241230
K904421CMS ONCOPROBE (TM)Cryomedical Sciences, Inc.1991-04-081930

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