Cleared Traditional

K900700 - SMU 611 UNIVERSALMONITOR

K900700 is an FDA 510(k) clearance for SMU 611 UNIVERSALMONITOR, manufactured by Ppg Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K900700 · Ppg Industries, Inc. · Cardiovascular device
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Apr 1990
Decision
50d
Days
Class 2
Risk

K900700 is an FDA 510(k) clearance for the SMU 611 UNIVERSALMONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Lenexa, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K900700

510(k) Number K900700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1990
Decision Date April 03, 1990
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 493
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K900700.
MODEL ECG100 SIMULATOR
K897029 · Dynatech/Nevada, Inc. · Apr 1990
TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990
PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
K901032 · Accucore, Inc. · Apr 1990
CARDIOCAP(TM) CMX-104 MONITOR
K896190 · Datex Division Instrumentarium Corp. · Mar 1990
EKG, ECG KENZ, ECG 303
K896772 · Cambridge Medical Instruments, Inc. · Feb 1990
CIRCAMED HOLTER VERSION 4
K894956 · Circadian, Inc. · Feb 1990
K900700 · SMU 611 UNIVERSALMONITOR
Download PDF Ppg Industries, Inc.