Cleared Traditional

K863158 - MODEL T-1 OXYGEN ANALYZER

K863158 is an FDA 510(k) clearance for MODEL T-1 OXYGEN ANALYZER, manufactured by Chrysalis Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K863158 · Chrysalis Systems, Inc. · Anesthesiology device
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Nov 1986
Decision
87d
Days
Class 2
Risk

K863158 is an FDA 510(k) clearance for the MODEL T-1 OXYGEN ANALYZER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Chrysalis Systems, Inc. (Idaho Springs, US). The FDA issued a Cleared decision on November 13, 1986 after a review of 87 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.

FDA 510(k) Submission Details - K863158

510(k) Number K863158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1986
Decision Date November 13, 1986
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
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 87
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K863158.
SL02 OXYGEN ANALYZER
K881472 · Salter Labs · Jun 1988
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K872001 · Medical, Inc. · Jun 1987
MODEL A-1 OXYGEN ANALYZER
K863806 · Medical, Inc. · Oct 1986
SERVO GAS MONITOR 120
K861625 · Siemens Elema AB · May 1986
EMERSON MODEL 3MV-OAA ALARM MODULE
K854799 · J. H. Emerson Co. · Dec 1985
K863158 · MODEL T-1 OXYGEN ANALYZER
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