510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021764Substantially Equivalent

Rusch Tracheofix Set, Cuffed and Uncuffed

Rusch Intl., Jeffrey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021764 is the FDA 510(k) clearance record for RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED, a class II device, cleared for Rusch Intl. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 43 510(k) clearances for Rusch Intl., from to . As of , FDA records show no recalls naming K021764.

Clearance record

Decision date
Received
(55 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Rusch Intl. Tall Pines Park, Jeffrey NH
510(k) summary
Summary PDF
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