Cleared Traditional

K864748 - PM-8 HEART RATE MONITOR

K864748 is an FDA 510(k) clearance for PM-8 HEART RATE MONITOR, manufactured by Pulse Time Products, Ltd.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K864748 · Pulse Time Products, Ltd. · Cardiovascular device
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Mar 1987
Decision
105d
Days
Class 2
Risk

K864748 is an FDA 510(k) clearance for the PM-8 HEART RATE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Pulse Time Products, Ltd. (Chichester, W. Sussex, GB). The FDA issued a Cleared decision on March 20, 1987 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 870.2300 - 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 Pulse Time Products, Ltd. devices

FDA 510(k) Submission Details - K864748

510(k) Number K864748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date March 20, 1987
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
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.

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 222
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K864748.
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
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SERIES 2000 BEDSIDE PATIENT MONITOR
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COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · Advantage Medical Systems, Inc. · Dec 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986
LIFE-WATCH MONITOR LT-8
K863534 · Computerized Medical Systems, Inc. · Nov 1986