Cleared Traditional

K880505 - ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301

K880505 is an FDA 510(k) clearance for ECG/RESPIRATION/ARRHYTHMIA MODULE FOR R..., manufactured by Ppg Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K880505 · Ppg Industries, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
326d
Days
Class 2
Risk

K880505 is an FDA 510(k) clearance for the ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Pleasantville, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K880505

510(k) Number K880505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1988
Decision Date December 27, 1988
Days to Decision 326 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 125d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 270
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K880505.
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · Siemens Medical Solutions USA, Inc. · Mar 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · Del Mar Avionics · Feb 1989
E550 ELECTROCARDIOGRAPH
K883440 · Burdick Corp. · Jan 1989
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988
EPICARDIA PC/FC
K883103 · Medicomp, Inc. · Sep 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · Mennen Medical, Inc. · Jul 1988