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

Instrumed International, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time
189 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7Instrumed International, Inc.2010-08-311890
K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXInstrumed International, Inc.2010-04-29650
K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALInstrumed International, Inc.2009-12-03790
K092544INSTRUMED VASCULAR CLAMPSInstrumed International, Inc.2009-10-26680
K081651INSTRUMED RONGEURInstrumed International, Inc.2008-08-08570
K071771INSTRUMED RETRACTORSInstrumed International, Inc.2007-08-02340
K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESInstrumed International, Inc.2004-04-16140

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