510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K032112Substantially Equivalent

P0rtex Reinforced Tracheal Tube (Cuffed and Uncuffed)

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

K032112 is the FDA 510(k) clearance record for P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED), a class II device, cleared for Portex , Ltd. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K032112.

Clearance record

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

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