510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911257Substantially Equivalent

Mr-5200 Full Disclosure System

Mennen Medical, Inc., Clarence NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911257 is the FDA 510(k) clearance record for MR-5200 FULL DISCLOSURE SYSTEM, a class II device, cleared for Mennen Medical, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 55 510(k) clearances for Mennen Medical, Inc., from to . As of , FDA records show no recalls naming K911257.

Clearance record

Decision date
Received
(151 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Mennen Medical, Inc. 10123 Main St., Clarence NY
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260