510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792214Substantially Equivalent

Model Tm2-Behind-the-Ear Tinnitus

Starkey Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792214 is the FDA 510(k) clearance record for MODEL TM2-BEHIND-THE-EAR TINNITUS, a class II device, cleared for Starkey Laboratories, Inc. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 61 510(k) clearances for Starkey Laboratories, Inc., from to . As of , FDA records show no recalls naming K792214.

Clearance record

Decision date
Received
(25 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Starkey Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BWF

Trailing 12 months

FDA records hold no clearances under product code BWF in the trailing twelve months.

FDA records show no clearances under product code BWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWF, 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 20260
October 20260