Cleared Traditional

K781339 - ENDOTRACHEAL TUBE

K781339 is an FDA 510(k) clearance for ENDOTRACHEAL TUBE, manufactured by Life-Line Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K781339 · Life-Line Products, Inc. · Anesthesiology device
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Aug 1978
Decision
12d
Days
Class 2
Risk

K781339 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Life-Line Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1978 after a review of 12 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 - K781339

510(k) Number K781339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1978
Decision Date August 15, 1978
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
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 220
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K781339.
ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
K790312 · Respiratory Support Products, Inc. · Feb 1979
ADAPTER, C/D SUCTION
K781713 · Novametrix Medical Systems, Inc. · Dec 1978
SLICK SET, CUFFED
K781808 · Polamedco, Inc. · Nov 1978
SLICK SET
K780900 · Polamedco, Inc. · Jul 1978
FOME-CUF PVC
K780583 · Bivona Medical Technologies · May 1978
NORTON ENDOTRACHEAL
K771197 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1977
K781339 · ENDOTRACHEAL TUBE
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