510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043160Substantially Equivalent

Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/so

Tracoe Medical GmbH, Westborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043160 is the FDA 510(k) clearance record for TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO, a class II device, cleared for Tracoe Medical GmbH on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list 8 510(k) clearances for Tracoe Medical GmbH, from to . As of , FDA records show no recalls naming K043160.

Clearance record

Decision date
Received
(95 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Tracoe Medical GmbH 117 Flanders Rd., Westborough MA
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