510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851462Substantially Equivalent

Bfw Voice Generator

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

K851462 is the FDA 510(k) clearance record for BFW VOICE GENERATOR, a class II device, cleared for Bfw Laboratories, Inc. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 2 510(k) clearances for Bfw Laboratories, Inc., from to . As of , FDA records show no recalls naming K851462.

Clearance record

Decision date
Received
(46 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Bfw Laboratories, Inc. 10701 Red Cir. Dr., Minnetonka MN
Third party review
No

Clearances, product code BTO

Trailing 12 months
1 clearance under product code BTO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260