510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964245Substantially Equivalent

Precise, Tynmpanette, and Xacto Impression Kits

Starkey Laboratories, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964245 is the FDA 510(k) clearance record for PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS, a class I device, cleared for Starkey Laboratories, Inc. on under FDA product code ESD (Hearing Aid, Air-Conduction, Prescription). FDA's definition for product code ESD reads: "An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid". FDA records list 61 510(k) clearances for Starkey Laboratories, Inc., from to . As of , FDA records show no recalls naming K964245.

Clearance record

Decision date
Received
(103 days to decision)
Product code
ESD Hearing Aid, Air-Conduction, Prescription
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Starkey Laboratories, Inc. 6600-6700 Washington Ave.South, Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code ESD

Trailing 12 months

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

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