Cleared Traditional

K870181 - JOHNSON INTRATRACHEAL OXYGEN CATHETER SET

K870181 is an FDA 510(k) clearance for JOHNSON INTRATRACHEAL OXYGEN CATHETER SET, manufactured by Cook, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K870181 · Cook, Inc. · Anesthesiology device
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May 1987
Decision
119d
Days
Class 2
Risk

K870181 is an FDA 510(k) clearance for the JOHNSON INTRATRACHEAL OXYGEN CATHETER SET. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on May 14, 1987 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Cook, Inc. devices

FDA 510(k) Submission Details - K870181

510(k) Number K870181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1987
Decision Date May 14, 1987
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 65
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K870181.
PREFILLED WATER FOR IRRIGATION USP
K880316 · Automatic Liquid Packaging, Inc. · Feb 1988
PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
K880317 · Automatic Liquid Packaging, Inc. · Feb 1988
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247 · Shiley, Inc. · Feb 1988
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · Shiley, Inc. · Jan 1987
MINI-TRACH KIT
K862167 · Portex, Inc. · Aug 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267 · Bivona Medical Technologies · Jun 1986