Cleared Traditional

K943278 - TRACKER 2/TRACKER 3 HOLTER RECORDER

K943278 is the FDA 510(k) clearance for TRACKER 2/TRACKER 3 HOLTER RECORDER by Reynolds Medical , Ltd.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K943278 · Reynolds Medical , Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
105d
Days
Class 2
Risk

K943278 is an FDA 510(k) clearance for the TRACKER 2/TRACKER 3 HOLTER RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Reynolds Medical , Ltd. (Hertford, GB). The FDA issued a Cleared decision on October 20, 1994 after a review of 105 days - within the typical 510(k) review window.

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 Reynolds Medical , Ltd. devices

Submission Details

510(k) Number K943278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date October 20, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
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 - DSH Recorder, Magnetic Tape, Medical

All 75
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K943278.
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