Cleared Traditional

K900700 - SMU 611 UNIVERSALMONITOR

K900700 is the FDA 510(k) clearance for SMU 611 UNIVERSALMONITOR by Ppg Industries, Inc.. It is a Class 2 Cardiovascular device (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.

View all Ppg Industries, Inc. devices

Submission Details

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
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.

Device Classification

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 170
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K900700.
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7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · Quinton, Inc. · Jan 1989