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

Medical Dynamics, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
224 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974542TRUE VISION, TRUE VISION IIMedical Dynamics, Inc.1998-02-17760
K921294VIDEO ENDOSCOPE-RIGID MODIFICATIONMedical Dynamics, Inc.1994-07-208550
K934682SURGICAL VIDEO CAMERA AND ACCESSORIESMedical Dynamics, Inc.1994-02-151380
K930568ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.1993-07-221770
K915538OVER THE WIRE STONE BASKETMedical Dynamics, Inc.1992-03-201010
K914315OPTICAL CATHETER INTRODUCER SETS, MODIFICATIONMedical Dynamics, Inc.1992-03-041810
K913986CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEMMedical Dynamics, Inc.1992-01-281450
K911296OPTICAL CATHETER ARTHROSCOPEMedical Dynamics, Inc.1991-09-241830
K903339VIDEO ENDOSCOPE, RIGIDMedical Dynamics, Inc.1991-03-062240
K904609XENON LIGHT SOURCEMedical Dynamics, Inc.1990-12-18680
K904113OPERATIVE RECORDING CAMERAMedical Dynamics, Inc.1990-10-30540
K900374ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.1990-04-20840
K896008MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.1989-12-27750
K895041OPTICAL CATHETER(TM) INTRODUCER SETSMedical Dynamics, Inc.1989-10-16680
K894319MEDICAL DYNAMICS LIGHT SOURCEMedical Dynamics, Inc.1989-10-03810
K891983CAM-WRAP(TM) NEW STERILIZATION PROCEDUREMedical Dynamics, Inc.1989-04-19220
K891236FDX SOLID STATE VIDEO CAMERA MODEL 5950Medical Dynamics, Inc.1989-04-05290
K884039MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940Medical Dynamics, Inc.1988-10-13170

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