Cleared Traditional

K990905 - PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPE...

K990905 is an FDA 510(k) clearance for PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPE..., 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 85-day FDA review.

K990905 · Passy-Muir, Inc. · Anesthesiology device
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Jun 1999
Decision
85d
Days
Class 2
Risk

K990905 is an FDA 510(k) clearance for the PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT. 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 June 11, 1999 after a review of 85 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 Passy-Muir, Inc. devices

FDA 510(k) Submission Details - K990905

510(k) Number K990905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1999
Decision Date June 11, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K990905.
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