510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030381Substantially Equivalent

Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula

Abbott Medical, England Ct21 6db, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030381 is the FDA 510(k) clearance record for PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA, a class II device, cleared for Portex , Ltd. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 2 recalls naming K030381.

Clearance record

Decision date
Received
(203 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Portex , Ltd. Military Rd., England Ct21 6db, GB
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