Atlas FDA

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

Cytocare, Inc. — Predicate Candidate Screening

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

62 daysmedian FDA review time
260 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954321ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)Cytocare, Inc.1995-10-13300
K952698ENDOCARE ELECTROSURGICAL HANDPIECECytocare, Inc.1995-08-14620
K952587ENDOCARE MONOPOLAR ELECTRODESCytocare, Inc.1995-07-17420
K942299ENDOCARE CRYOTHERAPY SYSTEMCytocare, Inc.1995-01-192520
K945054ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEMCytocare, Inc.1994-11-28450
K934211CYTOCARE DIODE LASER SYSTEMCytocare, Inc.1994-05-172600
K921708CYTOCARE LASER CATHETER FOR UROLOGYCytocare, Inc.1992-10-011740

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