Cleared Traditional

K943457 - AS/3 PRESSURE TEMPERATURE MODULE

K943457 is the FDA 510(k) clearance for AS/3 PRESSURE TEMPERATURE MODULE by Datex Division Instrumentarium Corp.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K943457 · Datex Division Instrumentarium Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
9d
Days
Class 2
Risk

K943457 is an FDA 510(k) clearance for the AS/3 PRESSURE TEMPERATURE MODULE, M-PT. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on July 27, 1994 after a review of 9 days - a notably fast clearance 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: 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K943457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date July 27, 1994
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
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 9
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K943457.
Endophys Blood Pressure Monitor model BPM-30
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MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979