Cleared Traditional

K912290 - HEALY/MONTGOMERY STENT SYSTEM (HMS SYST...

K912290 is an FDA 510(k) clearance for HEALY/MONTGOMERY STENT SYSTEM (HMS SYST..., 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 95-day FDA review.

K912290 · Boston Medical Products, Inc. · Anesthesiology device
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Aug 1991
Decision
95d
Days
Class 2
Risk

K912290 is an FDA 510(k) clearance for the HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (Waltham, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 95 days - within the typical 510(k) review window.

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: 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 Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K912290

510(k) Number K912290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date August 26, 1991
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
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 K912290.
ENDOTRACHEAL CPAP SET
K915277 · Vital Signs, Inc. · Mar 1992
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
K920900 · Polamedco, Inc. · Mar 1992
BIVONA SLEEP APNEA TUBE
K915799 · Bivona Medical Technologies · Feb 1992
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · Boston Medical Products, Inc. · Feb 1991
CUFFED LINDER NASOTRACHEAL AIRWAY
K900457 · Polamedco, Inc. · Apr 1990
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · The Kendal Co. · Jun 1989