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

Clearmedical, Inc. — Predicate Candidate Screening

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

257 daysmedian FDA review time
606 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033579REPROCESSED MULTIPLE CLIP APPLIERSClearmedical, Inc.2005-07-116060
K033578REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERSClearmedical, Inc.2005-07-116060
K033591REPROCESSED TROCARSClearmedical, Inc.2005-06-035680
K033592REPROCESSED SURGICAL SCISSORS AND GRASPERSClearmedical, Inc.2004-07-272570
K033593REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPSClearmedical, Inc.2003-11-2070
K031416CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCClearmedical, Inc.2003-07-15710
K012600CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25LClearmedical, Inc.2002-07-033240
K012609CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-2Clearmedical, Inc.2002-07-033240
K012622CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20Clearmedical, Inc.2002-07-033240
K012621CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENTClearmedical, Inc.2002-02-061770
K012601CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCASClearmedical, Inc.2002-02-061770
K012606CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENClearmedical, Inc.2002-02-061770
K012616CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGClearmedical, Inc.2002-02-061770
K012612CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGEClearmedical, Inc.2002-02-061770

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