Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

KMO · Predicate Candidate Screening

5 FDA 510(k) clearances under this product code; the 50 most recent screened below.

98 daysmedian FDA review time
539 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K9218524 SURE TM RECTAL TUBEBoston Pacific Medical, Inc.1993-10-085390
K893809COUGH PILLOWCustom Hospitals Products1989-08-28980
K883214THORACIC SUPPORT SYSTEMStorer Medical Products1989-01-171720
K882592HEART HUGGER STERNUM SUPPORT HARNESSGeneral Cardiac Technology, Inc.1988-09-20890
K792629STERILIZATION PROCESS/T-BINDERProcter & Gamble Mfg. Co.1980-01-11230

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