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

Graham Medical Products — Predicate Candidate Screening

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

189 daysmedian FDA review time
345 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921657VASECTOMY DRAPEGraham Medical Products1993-03-183450
K922100DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEGraham Medical Products1993-03-153150
K922059DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599Graham Medical Products1993-03-033090
K913447DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599Graham Medical Products1992-02-071890
K913448DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEGraham Medical Products1992-02-071890
K913560STOPCOCKGraham Medical Products1991-12-311440
K903726DRAPE, SURGICAL - UTILITY DRAPE - STERILEGraham Medical Products1990-08-27110
K863981STERILIZATION WRAPS #620,624,648,640,636,630,612Graham Medical Products1986-11-25420
K864111STERILE FIELD #605 FENESTRATED STERILE FIELD #606Graham Medical Products1986-10-3090

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