Cleared Traditional

K903900 - SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.

K903900 is an FDA 510(k) clearance for SMU 611 VERS. 2.0 INCLUDING PRESSNI, manufactured by Ppg Hellige B.V.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K903900

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.

DSK Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K903900.
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K896535 · Oxford Medilog, Inc. · Jan 1990
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K893232 · Camino Laboratories, Inc. · Jul 1989