Cleared Traditional

K841266 - MONTGOMERY TRACHEAL T-TUBE

K841266 is an FDA 510(k) clearance for MONTGOMERY TRACHEAL T-TUBE, manufactured by E. Benson Hood Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K841266 · E. Benson Hood Laboratories, Inc. · Anesthesiology device
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Jun 1984
Decision
80d
Days
Class 2
Risk

K841266 is an FDA 510(k) clearance for the MONTGOMERY TRACHEAL T-TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by E. Benson Hood Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 80 days - a notably fast clearance cycle.

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: 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 - K841266

510(k) Number K841266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1984
Decision Date June 14, 1984
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
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 128
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K841266.
PERCUTANEOUS CRICOTHYROIDOTOMY
K822440 · Frederic J. Toye, M.D. · Oct 1984
TRACHEAL TUBE 16 GAUGE-1.65MM-
K832466 · Erie Medical · Sep 1984
ALL-HANDS TRACHEOSTOMY CARE SET 0101
K842415 · All-Hands Medical Supply, Inc. · Jul 1984
PEDIA-TRAKE CRICOTHYROTOMY KIT
K840925 · Intl. Medical Devices , Ltd. · May 1984
COMMUNI-TRACH TUBE
K841546 · Implant Technology, Inc. · Apr 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984
K841266 · MONTGOMERY TRACHEAL T-TUBE
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