Cleared Traditional

K922438 - PRO2 OXYGEN ANALYZER

K922438 is an FDA 510(k) clearance for PRO2 OXYGEN ANALYZER, manufactured by Martech Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K922438 · Martech Medical Products, Inc. · Anesthesiology device
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Mar 1993
Decision
287d
Days
Class 2
Risk

K922438 is an FDA 510(k) clearance for the PRO2 OXYGEN ANALYZER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Martech Medical Products, Inc. (Temecula, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 287 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 Martech Medical Products, Inc. devices

FDA 510(k) Submission Details - K922438

510(k) Number K922438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date March 05, 1993
Days to Decision 287 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
147d slower than avg
Panel avg: 140d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 66
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K922438.
OXYCHECK OXYGEN MONITOR
K951038 · Oxycheck, Inc. · Jan 1996
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
K941793 · Mountain Medical Equipment, Inc. · Jun 1995
OXYGEN CONCENTRATION INDICATOR
K944654 · Aequitron Medical, Inc. · Nov 1994
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · Puritan Bennett Corp. · Aug 1992
OXYGEN SENSING DEVICE, MODIFICATION
K913392 · Devilbiss Health Care, Inc. · Jul 1992
BIOCHEM TEMPERATURE/ FIO2 MODULE
K910381 · Biochem International, Inc. · Aug 1991