510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951091Substantially Equivalent

Rusch Endobronchial Tube Sets

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

K951091 is the FDA 510(k) clearance record for RUSCH ENDOBRONCHIAL TUBE SETS, a class II device, cleared for Rusch Intl. on under FDA product code BTS (Tube, Bronchial (W/Wo Connector)). FDA records list 43 510(k) clearances for Rusch Intl., from to . As of , FDA records show 10 recalls naming K951091.

Clearance record

Decision date
Received
(91 days to decision)
Product code
BTS Tube, Bronchial (W/Wo Connector)
Regulation
21 CFR 868.5720
Device class
Class II
Review panel
Anesthesiology
Applicant
Rusch Intl. Tall Pines Park, Jeffrey NH
510(k) summary
Summary
Third party review
No

Clearances, product code BTS

Trailing 12 months

FDA records hold no clearances under product code BTS in the trailing twelve months.

FDA records show no clearances under product code BTS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTS, 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 20260
October 20260