510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K982617Substantially Equivalent

Tracer

Heartland Medical Systems, Inc., Newbury Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982617 is the FDA 510(k) clearance record for TRACER, a class II device, cleared for Heartland Medical Systems, Inc. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list one 510(k) clearance for Heartland Medical Systems, Inc. As of , FDA records show no recalls naming K982617.

Clearance record

Decision date
Received
(256 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Heartland Medical Systems, Inc. 725 Pickford Ct., Newbury Park CA
510(k) summary
Statement
Third party review
No

Clearances, product code MWJ

Trailing 12 months
5 clearances under product code MWJ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20261
September 20262
October 20260