510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082520Substantially Equivalent

Sealguard Evac Endotracheal and Endotracheal Tubes

Mallinckrodt Medical, Boulder CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082520 is the FDA 510(k) clearance record for SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES, a class II device, cleared for Mallinckrodt Medical on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 43 510(k) clearances for Mallinckrodt Medical, from to . As of , FDA records show 2 recalls naming K082520.

Clearance record

Decision date
Received
(30 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Mallinckrodt Medical 6135 Gunbarrel Ave., Boulder CO
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