Cleared Traditional

K821516 - TRACKER-2 CHANNEL ECG TAPE RECORDER

K821516 is the FDA 510(k) clearance for TRACKER-2 CHANNEL ECG TAPE RECORDER by Reynolds Medical , Ltd.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K821516 · Reynolds Medical , Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1982
Decision
7d
Days
Class 2
Risk

K821516 is an FDA 510(k) clearance for the TRACKER-2 CHANNEL ECG TAPE RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Reynolds Medical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reynolds Medical , Ltd. devices

Submission Details

510(k) Number K821516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1982
Decision Date May 28, 1982
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
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 K821516.
ELECTROCARDIOCORDER RECORDER 453
K833661 · Del Mar Avionics · Nov 1983
OMAR
K830915 · Oxford Medilog, Inc. · Jul 1983
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · Marquette Electronics, Inc. · Dec 1982
CASSETTE READER
K811253 · American Edwards Laboratories · Jul 1981
ADVANCEMED CCU DOCUMENTOR
K803222 · American Edwards Laboratories · Jan 1981
ADVANCEMED HOLTER RECORDERS
K803224 · American Edwards Laboratories · Jan 1981