Cleared Traditional

K880498 - RM-301 PATIENT MONITOR

K880498 is the FDA 510(k) clearance for RM-301 PATIENT MONITOR by Ppg Industries, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K880498 · Ppg Industries, Inc. · Cardiovascular device
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May 1988
Decision
98d
Days
Class 2
Risk

K880498 is an FDA 510(k) clearance for the RM-301 PATIENT MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Pleasantville, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 98 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 Ppg Industries, Inc. devices

Submission Details

510(k) Number K880498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1988
Decision Date May 13, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 89
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K880498.
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · Marquette Electronics, Inc. · Apr 1990
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · Marquette Electronics, Inc. · Jul 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986