Cleared Traditional

K892794 - PULSE TIME PRODUCTS LIMITED, PM-2

K892794 is an FDA 510(k) clearance for PULSE TIME PRODUCTS LIMITED, 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 130-day FDA review.

K892794 · Pulse Time Products, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
130d
Days
Class 2
Risk

K892794 is an FDA 510(k) clearance for the PULSE TIME PRODUCTS LIMITED, PM-2. 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 August 25, 1989 after a review of 130 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 - K892794

510(k) Number K892794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date August 25, 1989
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
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 K892794.
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · Fukuda Denshi USA, Inc. · Oct 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · S & W Medico Teknik · Oct 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · S & W Medico Teknik · Oct 1989
HORIZON CENTRAL STATION
K892066 · Mennen Medical, Inc. · Jun 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · Healthdyne, Inc. · May 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · S & W Medico Teknik · Apr 1989