Cleared Traditional

K921565 - CARDIOPULMONARY METABOLIC MEASUEMENT CART (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921565 · Quiton Instrument Co. · Anesthesiology device
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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

Submission Details

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
723d slower than avg
Panel avg: 139d · This submission: 862d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.