Cleared Traditional

K002067 - RADIANALYZER

K002067 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 Traditional 510(k) pathway after a 188-day FDA review.

K002067 · Radi Medical Systems AB · Cardiovascular device
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Jan 2001
Decision
188d
Days
Class 2
Risk

K002067 is an FDA 510(k) clearance for the RADIANALYZER, MODEL 12710. 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 January 11, 2001 after a review of 188 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.

View all Radi Medical Systems AB devices

FDA 510(k) Submission Details - K002067

510(k) Number K002067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2000
Decision Date January 11, 2001
Days to Decision 188 days
Submission Type Traditional
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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 37
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K002067.
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · Volcano Corporation · Dec 2015
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · Radi Medical Systems AB · Dec 2001
ZOLL M SERIES IBP OPERATION
K011865 · Zoll Medical Corp · Jul 2001
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · Datex Division Instrumentarium Corp. · Jul 1994
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
K921388 · Biochem International, Inc. · May 1993
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899 · Welch Allyn, Inc. · May 1993