Cleared Traditional

K982617 - TRACER

K982617 is an FDA 510(k) clearance for TRACER, manufactured by Heartland Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K982617 · Heartland Medical Systems, Inc. · Cardiovascular device
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Apr 1999
Decision
256d
Days
Class 2
Risk

K982617 is an FDA 510(k) clearance for the TRACER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Heartland Medical Systems, Inc. (Newbury Park, US). The FDA issued a Cleared decision on April 9, 1999 after a review of 256 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Heartland Medical Systems, Inc. devices

FDA 510(k) Submission Details - K982617

510(k) Number K982617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date April 09, 1999
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 27
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K982617.
DIGITRAKPLUS HOLTER RECORDER
K993617 · Braemar Corp. · Nov 1999
DXP1000 HOLTER RECORDER
K993618 · Braemar Corp. · Nov 1999
TES-20
K992425 · Tes Electrical Electronic Corp. · Oct 1999
CMS-2000
K982843 · Industrial Technology Research Institute · Nov 1998
DIGITAL ECG HOLTER RECORDER, MODEL DR512
K982975 · Datrix · Nov 1998