Cleared Traditional

K955516 - MONTGOMERY TRACHEOSTOMY SPEAKING VALVE

K955516 is an FDA 510(k) clearance for MONTGOMERY TRACHEOSTOMY SPEAKING VALVE, manufactured by Boston Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K955516 · Boston Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
18d
Days
Class 2
Risk

K955516 is an FDA 510(k) clearance for the MONTGOMERY TRACHEOSTOMY SPEAKING VALVE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 18 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.

View all Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K955516

510(k) Number K955516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date December 22, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 71
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K955516.
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
K960429 · Smiths Industries Medical Systems, Inc. · May 1996
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680 · Mallinckrodt Medical · Mar 1996
MALLINCKRODT SHILEY 15MM CAP
K954749 · Mallinckrodt Medical · Jan 1996
SUPERSLICK
K952700 · Bivona Medical Technologies · Oct 1995
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · Mallinckrodt Medical · Jan 1995
EUROMEDICAL POLY TRACHEOTOMY TUBE
K945874 · Regulatory & Marketing Services, Inc. · Dec 1994