Cleared Traditional

K890958 - OXITRON OXYGEN ANALYZER

K890958 is the FDA 510(k) clearance for OXITRON OXYGEN ANALYZER by Oxitron Medical Products. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K890958 · Oxitron Medical Products · Anesthesiology device
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May 1989
Decision
84d
Days
Class 2
Risk

K890958 is an FDA 510(k) clearance for the OXITRON OXYGEN ANALYZER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Oxitron Medical Products (Chatsworth, US). The FDA issued a Cleared decision on May 22, 1989 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oxitron Medical Products devices

Submission Details

510(k) Number K890958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date May 22, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 K890958.
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998
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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
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · Ohmeda Medical · Aug 1988
OHMEDA 5120 OXYGEN MONITOR
K853082 · Ohmeda Medical · Jul 1985