Cleared Traditional

K851335 - COACH TM- THE AEROBIC FITNESS MONITOR

K851335 is an FDA 510(k) clearance for COACH TM- THE AEROBIC FITNESS MONITOR, manufactured by Biotechnology, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K851335 · Biotechnology, Inc. · Cardiovascular device
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Jul 1985
Decision
112d
Days
Class 2
Risk

K851335 is an FDA 510(k) clearance for the COACH TM- THE AEROBIC FITNESS MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Biotechnology, Inc. (Miami, US). The FDA issued a Cleared decision on July 24, 1985 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Biotechnology, Inc. devices

FDA 510(k) Submission Details - K851335

510(k) Number K851335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1985
Decision Date July 24, 1985
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 228
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K851335.
SIRECUST 341 AND 341R
K854881 · Siemens Medical Solutions USA, Inc. · Mar 1986
ECS 502
K840717 · Robert Bosch Corp. · Aug 1985
VSM MODELS A & B
K851916 · Physio-Control Corp. · Aug 1985
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731 · Kontron Instruments, Inc. · May 1985
HORIZON 1000 CARDIAC MONITOR
K850880 · Mennen Medical, Inc. · Apr 1985