Starkey Laboratories, Inc.

Eden Prairie, MN, US

Starkey Laboratories, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 61 510(k) clearances between 1977-11-21 and 2020-06-19, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 61
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

Showing 50 of 61

FDA records hold 61 510(k) clearances for Starkey Laboratories, Inc. between 1977 and 2020. The busiest year on record is 1994, with 12. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Starkey Laboratories, Inc., by decision year
Year	Clearances
1977	2
1978	2
1979	9
1980	1
1982	1
1984	1
1988	5
1990	4
1991	1
1992	2
1993	8
1994	12
1996	7
1997	3
2003	1
2012	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K201370	Multiflex Tinnitus Technology	KLW	Substantially Equivalent	2020-06-19
K122876	MULTIFLEX TINNITUS TECHNOLOGY	KLW	Substantially Equivalent	2012-10-31
K030180	CRESCENT TINNITUS RETAINING SOUND GENERATOR	KLW	Substantially Equivalent	2003-09-17
K970952	PRECISE IMPRESSION KIT	ESD	Substantially Equivalent	1997-05-02
K964245	PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS	ESD	Substantially Equivalent	1997-02-04
K964340	PORTAREM-3000, PFS-6000	EWO	Substantially Equivalent	1997-01-10
K964216	STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER	KLW	Substantially Equivalent	1996-12-06
K964244	STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS	ESD	Substantially Equivalent	1996-11-27
K964214	STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS	ESD	Substantially Equivalent	1996-11-27
K963995	STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER	KLW	Substantially Equivalent	1996-11-26
K963838	STARKEY TM AIR CONDUCTION TINNITUS MASKER	KLW	Substantially Equivalent	1996-11-26
K963519	EUROLINE A-675 SERIS	ESD	Substantially Equivalent	1996-09-27
K960494	EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS	ESD	Substantially Equivalent	1996-03-01
K943460	PORTAREM 2000	ETW	Substantially Equivalent	1994-10-21
K943459	DESKREM-1000	ETW	Substantially Equivalent	1994-10-21
K943687	FEDELITY F495, VIENNATONE ALPP II	ESD	Substantially Equivalent	1994-10-20
K943682	SM-VEGA, SM-PC, SM-AGC, SM-AGC-H	ESD	Substantially Equivalent	1994-08-17
K940667	STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID	ESD	Substantially Equivalent	1994-08-09
K942594	STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID	ESD	Substantially Equivalent	1994-07-05
K942036	EUROSTAR SUPER, EUROSTAR VFC	ESD	Substantially Equivalent	1994-06-24
K932269	PRO-CONNECT	ESD	Substantially Equivalent	1994-05-13
K935701	VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229	LXB	Substantially Equivalent	1994-05-10
K941636	MINI PAK	ESD	Substantially Equivalent	1994-05-04
K941635	INTRA S, INTRA SH	ESD	Substantially Equivalent	1994-05-04
K940978	STARKEY EUROLINE A SERIES	ESD	Substantially Equivalent	1994-05-04
K934417	OMNI 2000 SERIES ITC HEARING AID	ESD	Substantially Equivalent	1993-11-29
K934416	OMNI 2000 SERIES ITE HEARING AID	ESD	Substantially Equivalent	1993-11-29
K933989	RESOLUTION ITC HEARING AID	ESD	Substantially Equivalent	1993-10-07
K933988	BOSCH EUROSTAR	ESD	Substantially Equivalent	1993-10-07
K933407	STARKEY TYMPANETTE HEARING AID	ESD	Substantially Equivalent	1993-10-07
K933113	STARKEY TRILOGY II PROGRAMMABLE HEARING AID	ESD	Substantially Equivalent	1993-07-27
K930853	INTRA V AND SECRET EAR III	ESD	Substantially Equivalent	1993-03-18
K930805	CE-9 IN-THE-EAR HEARING AID	ESD	Substantially Equivalent	1993-03-18
K922752	STARKEY LABORATORIES OTOSCOPE	ERA	Substantially Equivalent	1992-09-04
K923784	STARKEY SM SERIES BTE HEARING AIDS	ESD	Substantially Equivalent	1992-08-26
K911579	STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS	ESD	Substantially Equivalent	1991-05-07
K903145	HEARSET TELEPHONE HEARING SYSTEM	ESD	Substantially Equivalent	1990-12-21
K901833	CE-8 CUSTOM IN-THE-EAR HEARING AIDS	ESD	Substantially Equivalent	1990-08-09
K902068	HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER	EWO	Substantially Equivalent	1990-08-06
K901860	INTRA III AND INTRA IV HEARING AIDS	ESD	Substantially Equivalent	1990-07-20
K880969	STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES	ESD	Substantially Equivalent	1988-04-11
K880335	INTRA II SECRET EAR HEARING AIDS ISE	ESD	Substantially Equivalent	1988-03-18
K880334	CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7	ESD	Substantially Equivalent	1988-03-18
K880333	CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7	ESD	Substantially Equivalent	1988-03-18
K873031	STARKEY MODEL P1 MODULE	LRB	Substantially Equivalent	1988-02-08
K844275	STARKET MODEL HMS	ETW	Substantially Equivalent	1984-12-03
K821908	STARKEY MODEL HAL-1	ETW	Substantially Equivalent	1982-08-03
K802560	TINNITUS RESEARCH AUDIOMETER	EWO	Substantially Equivalent	1980-11-12
K792214	MODEL TM2-BEHIND-THE-EAR TINNITUS	BWF	Substantially Equivalent	1979-11-27
K791790	MODEL TM5 BEHIND EAR TINNITUS MASKER	KLW	Substantially Equivalent	1979-10-26

Registered establishments

FDA registered establishments for Starkey Laboratories, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2125608	2125608	Starkey Laboratories, Inc.	6700 Washington Ave S, EDEN PRAIRIE, MN 55344 US	2026	ESD KLW OSM

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain