Cleared Traditional

K823449 - RESPIRATORY GAS ANALYZER

K823449 is an FDA 510(k) clearance for RESPIRATORY GAS ANALYZER, manufactured by Thoratec Laboratories Corp.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K823449 · Thoratec Laboratories Corp. · Anesthesiology device
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Jan 1983
Decision
54d
Days
Class 2
Risk

K823449 is an FDA 510(k) clearance for the RESPIRATORY GAS ANALYZER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Thoratec Laboratories Corp. (Walker, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 54 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 Thoratec Laboratories Corp. devices

FDA 510(k) Submission Details - K823449

510(k) Number K823449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1982
Decision Date January 05, 1983
Days to Decision 54 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 140d · This submission: 54d
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 66
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K823449.
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