510(k) Report

FDA applicant

Starkey Laboratories, Inc.

Eden Prairie, MN61 decisions1977–20200 recalls

FDA records 61 decisions for Starkey Laboratories, Inc. (Eden Prairie, MN) from 1977 to 2020: 61 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and KLW (Masker, Tinnitus). Its devices cite 9 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Starkey Laboratories”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Starkey Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12020: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Starkey Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Starkey Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription39decisions
  • KLWMasker, Tinnitus10decisions
  • ETWCalibrator, Hearing Aid / Earphone And Analysis Systems4decisions
  • EWOAudiometer3decisions
  • KHLHearing Aid, Master1decision
  • BWFSpirometer, Therapeutic (Incentive)1decision

Also: ERA (1), LXB (1), LRB (1).

Whose devices does it build on?

Its devices cite 9 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K963838Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 19964cite it
  • K964216Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc. · 19964cite it
  • K791790Model TM5 Behind Ear Tinnitus MaskerStarkey Laboratories, Inc. · 19793cite it
  • K940667Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 19943cite it
  • K923784Starkey SM Series Bte Hearing AidsStarkey Laboratories, Inc. · 19922cite it
  • K122876Multiflex Tinnitus TechnologyStarkey Laboratories · 20121cites it

What has FDA decided for it lately?

  • K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc. · 2020
  • K122876Multiflex Tinnitus TechnologyStarkey Laboratories · 2012
  • K030180Crescent Tinnitus Retaining Sound GeneratorStarkey Laboratories, Inc. · 2003
  • K970952Precise Impression KitStarkey Laboratories, Inc. · 1997
  • K964245Precise, Tynmpanette, and Xacto Impression KitsStarkey Laboratories, Inc. · 1997
  • K964340Portarem-3000, PFS-6000Starkey Laboratories, Inc. · 1997
  • K964216Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc. · 1996
  • K964214Starkey a-13 Sequel Programmable, a-13 K-Amp Programmable Air Conduction Hearing AidsStarkey Laboratories, Inc. · 1996

All 60 as Starkey Laboratories, Inc. →The one decision as Starkey Laboratories →