510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981891Substantially Equivalent

Ambu Tubecheck

Ambu, Inc., Linthicum MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981891 is the FDA 510(k) clearance record for AMBU TUBECHECK, a class II device, cleared for Ambu, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 22 510(k) clearances for Ambu, Inc., from to . As of , FDA records show no recalls naming K981891.

Clearance record

Decision date
Received
(49 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Ambu, Inc. 611 N. Hammonds Ferry Rd., Linthicum MD
510(k) summary
Statement
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