510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K843988Substantially Equivalent

S.e.t. Tube

Bfw Laboratories, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843988 is the FDA 510(k) clearance record for S.E.T. TUBE, a class II device, cleared for Bfw Laboratories, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 2 510(k) clearances for Bfw Laboratories, Inc., from to . As of , FDA records show no recalls naming K843988.

Clearance record

Decision date
Received
(133 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Bfw Laboratories, Inc. 10701 Red Cir. Dr., Minnetonka MN
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