510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954661Substantially Equivalent

The Zipper Medical Combination Ventilator Anti-Disconncet Device & Tracheostomy Tube Neckband. Tracheostomy Tube Holder,

Zipper Medical, Inc., Silver Spring MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954661 is the FDA 510(k) clearance record for THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,, a class II device, cleared for Zipper Medical, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list one 510(k) clearance for Zipper Medical, Inc. As of , FDA records show no recalls naming K954661.

Clearance record

Decision date
Received
(101 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Zipper Medical, Inc. 10109 Day Ave., Silver Spring MD
510(k) summary
Statement
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