Cleared Traditional

K895935 - ICOR CMU Q PLUS

K895935 is an FDA 510(k) clearance for ICOR CMU Q PLUS, manufactured by Icor AB. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K895935 · Icor AB · Anesthesiology device
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Jan 1990
Decision
85d
Days
Class 2
Risk

K895935 is an FDA 510(k) clearance for the ICOR CMU Q PLUS. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on January 4, 1990 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - the FDA anesthesiology and respiratory device 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.

FDA 510(k) Submission Details - K895935

510(k) Number K895935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date January 04, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZL Computer, Oxygen-uptake

All 24
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K895935.
PHYSIO-DYNE EASI - LAB
K922660 · Physio-Dyne · Apr 1993
MEDGRAPHICS PF/DX
K912906 · Medical Graphics Corp. · Feb 1992
OXYMAX
K895791 · Columbus Instruments Intl. Corp. · Mar 1990
VVR/Q CALORIMETER
K895586 · Vita-Stat · Sep 1989
DELTATRAC(TM) METABOLIC MONITOR
K864603 · Datex Division Instrumentarium Corp. · Mar 1987
ERGO-PNEUMOTEST
K853434 · Erich Jaeger, Inc. · Feb 1986
K895935 · ICOR CMU Q PLUS
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