510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100995Substantially Equivalent

Shikani Speaking Valve

Shikani Medical LLC, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100995 is the FDA 510(k) clearance record for SHIKANI SPEAKING VALVE, a class II device, cleared for Shikani Medical, LLC on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list one 510(k) clearance for Shikani Medical, LLC. As of , FDA records show no recalls naming K100995.

Clearance record

Decision date
Received
(77 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Shikani Medical, LLC 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOH

Trailing 12 months
1 clearance under product code JOH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260