Cleared Traditional

K912816 - PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE (FDA 510(k) Clearance)

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

K912816 · S & W Medico Teknik · Cardiovascular device
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Apr 1992
Decision
297d
Days
Class 2
Risk

K912816 is an FDA 510(k) clearance for the PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on April 10, 1992 after a review of 297 days - an extended review cycle.

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.

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Submission Details

510(k) Number K912816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date April 10, 1992
Days to Decision 297 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 125d · This submission: 297d
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.