Cleared Traditional

K982128 - SHIKANI-FRENCH SPEAKING VALVE

K982128 is an FDA 510(k) clearance for SHIKANI-FRENCH SPEAKING VALVE, manufactured by Pilling Weck Surgical. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K982128 · Pilling Weck Surgical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
128d
Days
Class 2
Risk

K982128 is an FDA 510(k) clearance for the SHIKANI-FRENCH SPEAKING VALVE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Pilling Weck Surgical (Fort Washington, US). The FDA issued a Cleared decision on October 23, 1998 after a review of 128 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 Pilling Weck Surgical devices

FDA 510(k) Submission Details - K982128

510(k) Number K982128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date October 23, 1998
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 76
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K982128.
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