Cleared Traditional

K881663 - OXYGEN/TEMPERATURE ANALYZER MODEL 300 S...

K881663 is an FDA 510(k) clearance for OXYGEN/TEMPERATURE ANALYZER MODEL 300 S..., manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K881663 · Salter Labs · Anesthesiology device
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Aug 1988
Decision
126d
Days
Class 2
Risk

K881663 is an FDA 510(k) clearance for the OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on August 19, 1988 after a review of 126 days - within the typical 510(k) review window.

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 Salter Labs devices

FDA 510(k) Submission Details - K881663

510(k) Number K881663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date August 19, 1988
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
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 42
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K881663.
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
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MULTINEX MONITOR (MODIFICATION)
K883254 · Datascope Corp. · Sep 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · Ohmeda Medical · Aug 1988
SL02 OXYGEN ANALYZER
K881472 · Salter Labs · Jun 1988
SL01 OXYGEN ANALYZER
K881473 · Salter Labs · Jun 1988
SERVO GAS MONITOR 120
K861625 · Siemens Elema AB · May 1986