Cleared Traditional

K833995 - MINI OX II

K833995 is the FDA 510(k) clearance for MINI OX II by Catalyst Research Corp.. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K833995 · Catalyst Research Corp. · Anesthesiology device
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Dec 1983
Decision
21d
Days
Class 2
Risk

K833995 is an FDA 510(k) clearance for the MINI OX II. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Catalyst Research Corp. (Walker, US). The FDA issued a Cleared decision on December 12, 1983 after a review of 21 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 Catalyst Research Corp. devices

Submission Details

510(k) Number K833995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date December 12, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 140d · This submission: 21d
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 K833995.
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · Ohmeda Medical · Aug 1988
OHMEDA 5120 OXYGEN MONITOR
K853082 · Ohmeda Medical · Jul 1985
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645 · Gambro, Inc. · Apr 1984
OXYMED
K831238 · Draeger Medical, Inc. · May 1983
OPTION A02 MODEL 15202A
K830124 · Hewlett-Packard Co. · Feb 1983
OXYGEN MONITOR IL 408
K823374 · Instrumentation Laboratory CO · Dec 1982