510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K961840Substantially Equivalent

Rusch Oral/nasal Tracheal Tube, Plain Magill/murphy

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

K961840 is the FDA 510(k) clearance record for RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY, a class II device, cleared for Rusch Intl. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 43 510(k) clearances for Rusch Intl., from to . As of , FDA records show 24 recalls naming K961840.

Clearance record

Decision date
Received
(45 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
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 BTR

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