Cleared Traditional

K954661 - THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER, (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954661 · Zipper Medical, Inc. · Anesthesiology device
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Jan 1996
Decision
101d
Days
Class 2
Risk

K954661 is an FDA 510(k) clearance for the THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTO.... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Zipper Medical, Inc. (Silver Spring, US). The FDA issued a Cleared decision on January 19, 1996 after a review of 101 days - within the typical 510(k) review window.

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 Zipper Medical, Inc. devices

Submission Details

510(k) Number K954661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date January 19, 1996
Days to Decision 101 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
38d faster than avg
Panel avg: 139d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 108
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K954661.
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K193077 · Covidien · Jun 2020