510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080339Substantially Equivalent

Medsource Endotracheal Tube (with and without Cuff)

Medsource International, LLC, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080339 is the FDA 510(k) clearance record for MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF), a class II device, cleared for Medsource International, LLC on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 10 510(k) clearances for Medsource International, LLC, from to . As of , FDA records show no recalls naming K080339.

Clearance record

Decision date
Received
(262 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Medsource International, LLC 11715 Fox Rd. Suite 400-180, Indianapolis IN
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 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