510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050896Substantially Equivalent

H12+ Holter Recorder

Mortara Instrument, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050896 is the FDA 510(k) clearance record for H12+ HOLTER RECORDER, a class II device, cleared for Mortara Instrument, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 51 510(k) clearances for Mortara Instrument, Inc., from to . As of , FDA records show one recall naming K050896.

Clearance record

Decision date
Received
(138 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Mortara Instrument, Inc. 7865 N. 86th St., Milwaukee WI
510(k) summary
Summary PDF
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