Cleared Traditional

K922438 - PRO2 OXYGEN ANALYZER

K922438 is the FDA 510(k) clearance for PRO2 OXYGEN ANALYZER by Martech Medical Products, Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

Device Classification

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 20
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K922438.
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295 · Invacare Corp. · Jul 1999
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · Puritan Bennett Corp. · Aug 1992
AG-820PA FI02 MODULE
K896359 · Nihon Kohden America, Inc. · Mar 1990
MULTINEX MONITOR (MODIFICATION)
K883254 · Datascope Corp. · Sep 1988