510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K032103Substantially Equivalent

Philips Tracemaster ECG Management System, Models M5100a and M5101a

Philips North America LLC, Andover MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032103 is the FDA 510(k) clearance record for PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A, a class II device, cleared for Philips Medical Systems on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K032103.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems 3000 Minuteman Rd., Andover MA
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 November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260