Cleared Traditional

K921565 - CARDIOPULMONARY METABOLIC MEASUEMENT CART

K921565 is an FDA 510(k) clearance for CARDIOPULMONARY METABOLIC MEASUEMENT CART, manufactured by Quiton Instrument Co.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 862-day FDA review.

K921565 · Quiton Instrument Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
862d
Days
Class 2
Risk

K921565 is an FDA 510(k) clearance for the CARDIOPULMONARY METABOLIC MEASUEMENT CART. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Quiton Instrument Co. (Seattle, US). The FDA issued a Cleared decision on August 11, 1994 after a review of 862 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Quiton Instrument Co. devices

FDA 510(k) Submission Details - K921565

510(k) Number K921565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1992
Decision Date August 11, 1994
Days to Decision 862 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
722d slower than avg
Panel avg: 140d · This submission: 862d
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 21
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K921565.
BODYGEM, MODEL HB211
K010577 · Healthetech, Inc. · Jan 2002
OXYLOG 2
K954731 · P.K. Morgan , Ltd. · Jan 1997
7250 METABOLIC MONITOR
K924978 · Puritan Bennett Corp. · Sep 1994
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