Cleared Traditional

K944451 - PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES...

K944451 is an FDA 510(k) clearance for PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES..., manufactured by Passy-Muir, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K944451 · Passy-Muir, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
298d
Days
Class 2
Risk

K944451 is an FDA 510(k) clearance for the PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES). Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Passy-Muir, Inc. (Irvine, US). The FDA issued a Cleared decision on July 7, 1995 after a review of 298 days - an extended review 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: 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 Passy-Muir, Inc. devices

FDA 510(k) Submission Details - K944451

510(k) Number K944451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date July 07, 1995
Days to Decision 298 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 140d · This submission: 298d
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 62
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K944451.
MALLINCKRODT SHILEY 15MM CAP
K954749 · Mallinckrodt Medical · Jan 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955516 · Boston Medical Products, Inc. · Dec 1995
SUPERSLICK
K952700 · Bivona Medical Technologies · Oct 1995
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · Mallinckrodt Medical · Jan 1995
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993