Cleared Traditional

K955634 - MONTGOMERY TRACHEOSTOMY SPEAKING VALVE

K955634 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 CBP cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K955634 · Boston Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
182d
Days
Class 2
Risk

K955634 is an FDA 510(k) clearance for the MONTGOMERY TRACHEOSTOMY SPEAKING VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on June 10, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 - K955634

510(k) Number K955634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date June 10, 1996
Days to Decision 182 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
42d slower than avg
Panel avg: 140d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 37
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K955634.
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725 · Instrumentation Industries, Inc. · Aug 1998
NON-REBREATHING 'T' (BE 117)
K973066 · Instrumentation Industries, Inc. · Feb 1998
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · Instrumentation Industries, Inc. · Sep 1997
K.P.R. (KING PERSONAL RESUSCITATOR)
K943402 · King Systems Corp. · Aug 1994
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · Sechrist Industries, Inc. · Dec 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988 · Dhd Medical Products Div. Diemolding Corp. · Oct 1988