Cleared Special

K013943 - RADIANALYZER

K013943 is an FDA 510(k) clearance for RADIANALYZER, manufactured by Radi Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Special 510(k) pathway after a 19-day FDA review.

K013943 · Radi Medical Systems AB · Cardiovascular device
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Dec 2001
Decision
19d
Days
Class 2
Risk

K013943 is an FDA 510(k) clearance for the RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on December 18, 2001 after a review of 19 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radi Medical Systems AB devices

FDA 510(k) Submission Details - K013943

510(k) Number K013943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2001
Decision Date December 18, 2001
Days to Decision 19 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K013943.
Endophys Blood Pressure Monitor model BPM-30
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K011865 · Zoll Medical Corp · Jul 2001
RADIANALYZER, MODEL 12710
K002067 · Radi Medical Systems AB · Jan 2001
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · Datex Division Instrumentarium Corp. · Jul 1994
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K921388 · Biochem International, Inc. · May 1993