Cleared Traditional

K864161 - TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER

K864161 is an FDA 510(k) clearance for TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER, manufactured by Toob-Cheq, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K864161 · Toob-Cheq, Inc. · Anesthesiology device
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Nov 1986
Decision
18d
Days
Class 2
Risk

K864161 is an FDA 510(k) clearance for the TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Toob-Cheq, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on November 10, 1986 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 - K864161

510(k) Number K864161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date November 10, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 219
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K864161.
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870387 · American Pharmaseal Div. Ahsc · May 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · Mallinckrodt Critical Care · Apr 1987
HOOD BIFURCATED T-TUBE
K864533 · Hood Laboratories · Mar 1987
WHITE-SIPOSS TUBE, CAT NO WS-1
K862950 · American Omni Medical, Inc. · Oct 1986
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
K862238 · Bivona Medical Technologies · Oct 1986
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · Mallinckrodt Critical Care · Aug 1986
K864161 · TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
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