Cleared Traditional

K843936 - MONTGOMERY SAFE-T-TUBE

K843936 is an FDA 510(k) clearance for MONTGOMERY SAFE-T-TUBE, manufactured by Boston Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K843936 · Boston Medical Products, Inc. · Anesthesiology device
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Dec 1984
Decision
66d
Days
Class 2
Risk

K843936 is an FDA 510(k) clearance for the MONTGOMERY SAFE-T-TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (Boston, US). The FDA issued a Cleared decision on December 14, 1984 after a review of 66 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 Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K843936

510(k) Number K843936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date December 14, 1984
Days to Decision 66 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
74d faster than avg
Panel avg: 140d · This submission: 66d
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 150
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K843936.
UNCUFFED HI-LO JET TRACHEAL TUBE
K852493 · Mallinckrodt Critical Care · Jul 1985
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · Sherwood Medical Co. · Feb 1985
TRACHEAL TUBE W/AIRWAY INTUBATOR
K844746 · Sheridan Catheter Corp. · Jan 1985
TRACHEAL TUBE, REINFORCED, CUFFED
K844296 · Sheridan Catheter Corp. · Dec 1984
DOUBLE CONTOURED CUFF TRACHEAL TUBE
K843714 · Ohmeda Medical · Oct 1984
UNCUFFED REINFORCED TRACHEAL TUBE
K841872 · Mallinckrodt Critical Care · Jul 1984