Cleared Traditional

K812879 - OHIO NON-REUSABLE TRACHEAL TUBE MURPHY

K812879 is the FDA 510(k) clearance for OHIO NON-REUSABLE TRACHEAL TUBE MURPHY by Airco/Ohio Medical Products. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K812879 · Airco/Ohio Medical Products · Anesthesiology device
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Nov 1981
Decision
41d
Days
Class 2
Risk

K812879 is an FDA 510(k) clearance for the OHIO NON-REUSABLE TRACHEAL TUBE MURPHY. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Airco/Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 41 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.

View all Airco/Ohio Medical Products devices

Submission Details

510(k) Number K812879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1981
Decision Date November 24, 1981
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 66
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K812879.
ARGYLE TARTAN I TRACHEAL TUBE
K821670 · Sherwood Medical Co. · Jun 1982
TRACELON
K821180 · Terumo Medical Corp. · May 1982
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · Shiley, Inc. · May 1982
ARGYLE TARTAN TRACHEAL TUBE
K811937 · Sherwood Medical Co. · Jul 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · Mallinckrodt Critical Care · Jul 1981
CONCEPT ENDOTRACHEAL TUBE
K801213 · Concept, Inc. · May 1980