Cleared Traditional

K863640 - MODIFIED GAS SAMPLING KIT

K863640 is an FDA 510(k) clearance for MODIFIED GAS SAMPLING KIT, manufactured by Respiratory Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K863640 · Respiratory Support Products, Inc. · Anesthesiology device
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Oct 1986
Decision
35d
Days
Class 2
Risk

K863640 is an FDA 510(k) clearance for the MODIFIED GAS SAMPLING KIT. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Respiratory Support Products, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 8, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Respiratory Support Products, Inc. devices

FDA 510(k) Submission Details - K863640

510(k) Number K863640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date October 08, 1986
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 176
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K863640.
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K862543 · Analytical Products, Inc. · Jul 1986
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K861213 · Datex Division Instrumentarium Corp. · Apr 1986