Cleared Traditional

K854927 - ICOR CALARIC MEASUREMENT UNIT (CMU)

K854927 is an FDA 510(k) clearance for ICOR CALARIC MEASUREMENT UNIT (CMU), 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 107-day FDA review.

K854927 · Icor AB · Anesthesiology device
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Mar 1986
Decision
107d
Days
Class 2
Risk

K854927 is an FDA 510(k) clearance for the ICOR CALARIC MEASUREMENT UNIT (CMU). 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 March 27, 1986 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Icor AB devices

FDA 510(k) Submission Details - K854927

510(k) Number K854927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date March 27, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 14
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K854927.
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · Datex Division Instrumentarium Corp. · Nov 1993
MEDGRAPHICS PF/DX
K912906 · Medical Graphics Corp. · Feb 1992
DELTATRAC(TM) METABOLIC MONITOR
K864603 · Datex Division Instrumentarium Corp. · Mar 1987
ERGO-PNEUMOTEST
K853434 · Erich Jaeger, Inc. · Feb 1986
METABOLIC MEASUREMENT CART
K822710 · Beckman Instruments, Inc. · Oct 1982
ENGSTROM METABOLIC COMPUTER
K821344 · Lkb Instruments, Inc. · May 1982