510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945406Substantially Equivalent

Ssv Phonate(tm) Shiley Speaking Valve

Mallinckrodt Medical Tpi, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945406 is the FDA 510(k) clearance record for SSV PHONATE(TM) SHILEY SPEAKING VALVE, a class II device, cleared for Mallinckrodt Medical Tpi, Inc. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 4 510(k) clearances for Mallinckrodt Medical Tpi, Inc., from to . As of , FDA records show no recalls naming K945406.

Clearance record

Decision date
Received
(116 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Mallinckrodt Medical Tpi, Inc. 1595 Deere Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code BTO

Trailing 12 months
1 clearance under product code BTO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260