510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904113Substantially Equivalent

Operative Recording Camera

Medical Dynamics, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904113 is the FDA 510(k) clearance record for OPERATIVE RECORDING CAMERA, a class II device, cleared for Medical Dynamics, Inc. on under FDA product code IKO (Hammer, Reflex, Powered). FDA records list 18 510(k) clearances for Medical Dynamics, Inc., from to . As of , FDA records show no recalls naming K904113.

Clearance record

Decision date
Received
(54 days to decision)
Product code
IKO Hammer, Reflex, Powered
Regulation
21 CFR 890.1450
Device class
Class II
Review panel
Physical Medicine
Applicant
Medical Dynamics, Inc. 99 Inverness Dr. E., Englewood CO
Third party review
No

Clearances, product code IKO

Trailing 12 months

FDA records hold no clearances under product code IKO in the trailing twelve months.

FDA records show no clearances under product code IKO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260