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

International Hospital Supply Co. · Predicate Candidate Screening

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

79 daysmedian FDA review time
84 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040853PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101International Hospital Supply Co.2004-06-21810
K033040PHOENIX INFANT RADIANT WARMER, MODEL 100NWSInternational Hospital Supply Co.2003-12-17790
K911982BONE NAIL, KUNTSCHERInternational Hospital Supply Co.1991-07-26840
K911377FORCEPS, COAGULATION, BIPOLAR, MALISInternational Hospital Supply Co.1991-04-19220
K910621BLADES FOR SPINAL LAMINECTOMY RETRACTORInternational Hospital Supply Co.1991-04-01480

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