510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934465Substantially Equivalent

Dic Tracheostomy Tube and Portex Blue Line

Smiths Industries Medical Systems, Inc., Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934465 is the FDA 510(k) clearance record for DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE, a class II device, cleared for Smiths Industries Medical Systems, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 22 510(k) clearances for Smiths Industries Medical Systems, Inc., from to . As of , FDA records show 2 recalls naming K934465.

Clearance record

Decision date
Received
(123 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Industries Medical Systems, Inc. 15 Kit St., Keene 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