Cleared Traditional

K880505 - ECG/RESPIRATION/ARRHYTHMIA MODULE FOR R...

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

K880505 · Ppg Industries, Inc. · Cardiovascular device
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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

Submission Details

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
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.

Device Classification

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 127
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K880505.
SEER
K882818 · Marquette Electronics, Inc. · Jun 1989
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
K890323 · Marquette Electronics, Inc. · Jun 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · Siemens Medical Solutions USA, Inc. · Mar 1989
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · Nihon Kohden America, Inc. · Sep 1987