Cleared Traditional

K922660 - PHYSIO-DYNE EASI - LAB

K922660 is an FDA 510(k) clearance for PHYSIO-DYNE EASI - LAB, manufactured by Physio-Dyne. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K922660 · Physio-Dyne · Anesthesiology device
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Apr 1993
Decision
309d
Days
Class 2
Risk

K922660 is an FDA 510(k) clearance for the PHYSIO-DYNE EASI - LAB. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Physio-Dyne (Massapequa, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 309 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Physio-Dyne devices

FDA 510(k) Submission Details - K922660

510(k) Number K922660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date April 08, 1993
Days to Decision 309 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 140d · This submission: 309d
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 K922660.
OXYLOG 2
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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