Cleared Traditional

SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. (K903900) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903900 · Ppg Hellige B.V. · Cardiovascular device
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Jan 1991
Decision
138d
Days
Class 2
Risk

K903900 is an FDA 510(k) clearance for the SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Ppg Hellige B.V. (West Germany, DE). The FDA issued a Cleared decision on January 8, 1991 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Hellige B.V. devices

Submission Details

510(k) Number K903900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1990
Decision Date January 08, 1991
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 76
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K903900.
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K771977 · Instrumentation Laboratory CO · Jan 1978