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

Circon Video — Predicate Candidate Screening

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

90 daysmedian FDA review time
379 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRCircon Video2002-04-092350
K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2Circon Video2002-01-082070
K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MRCircon Video2001-12-101800
K012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735Circon Video2001-11-19800
K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPECircon Video2001-11-09660
K012925DUR-8, MODELS DUR-8Circon Video2001-11-07680
K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088Circon Video2001-10-17900
K012153LOWSLEY SUPRAPUBIC TRACTORCircon Video2001-09-19700
K011848CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBECircon Video2001-09-11900
K970595CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMPCircon Video1997-10-242480
K914883CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURGCircon Video1993-01-154430
K914101CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATORCircon Video1991-11-22710
K911053CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENTCircon Video1991-06-03870
K890328ADULT RESECTOSCOPECircon Video1990-02-063794

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