510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083119Substantially Equivalent

Portex Tracheal Tube, Sizes 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5

Abbott Medical, Hythe, Kent, GB / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083119 is the FDA 510(k) clearance record for PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, a class II device, cleared for Smiths Medical Asd, Inc. 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 K083119.

Clearance record

Decision date
Received
(247 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 Medical Asd, Inc. Boundary Rd., Hythe, Kent, 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