Cleared Traditional

K823695 - CPM METABOLIC MONITOR

K823695 is an FDA 510(k) clearance for CPM METABOLIC MONITOR, manufactured by Medicor USA , Ltd.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K823695 · Medicor USA , Ltd. · Anesthesiology device
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Jan 1983
Decision
37d
Days
Class 2
Risk

K823695 is an FDA 510(k) clearance for the CPM METABOLIC MONITOR. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Medicor USA , Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 37 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.

View all Medicor USA , Ltd. devices

FDA 510(k) Submission Details - K823695

510(k) Number K823695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1982
Decision Date January 14, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 140d · This submission: 37d
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 18
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K823695.
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
BECKMAN MMC II METABOLIC MEAS. CART
K820905 · Beckman Instruments, Inc. · May 1982