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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Starkey Laboratories, Inc. — Predicate Candidate Screening

60 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

45 daysmedian FDA review time
156 days90th percentile
60clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.2020-06-19280
K030180CRESCENT TINNITUS RETAINING SOUND GENERATORStarkey Laboratories, Inc.2003-09-172430
K970952PRECISE IMPRESSION KITStarkey Laboratories, Inc.1997-05-02490
K964245PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITSStarkey Laboratories, Inc.1997-02-041030
K964340PORTAREM-3000, PFS-6000Starkey Laboratories, Inc.1997-01-10710
K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKERStarkey Laboratories, Inc.1996-12-06450
K964244STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIStarkey Laboratories, Inc.1996-11-27340
K964214STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIStarkey Laboratories, Inc.1996-11-27360
K963995STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUSStarkey Laboratories, Inc.1996-11-26530
K963838STARKEY TM AIR CONDUCTION TINNITUS MASKERStarkey Laboratories, Inc.1996-11-26630
K963519EUROLINE A-675 SERISStarkey Laboratories, Inc.1996-09-27240
K960494EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARINStarkey Laboratories, Inc.1996-03-01310
K943459DESKREM-1000Starkey Laboratories, Inc.1994-10-21950
K943460PORTAREM 2000Starkey Laboratories, Inc.1994-10-21950
K943687FEDELITY F495, VIENNATONE ALPP IIStarkey Laboratories, Inc.1994-10-20830
K943682SM-VEGA, SM-PC, SM-AGC, SM-AGC-HStarkey Laboratories, Inc.1994-08-17220
K940667STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AIStarkey Laboratories, Inc.1994-08-091740
K942594STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AIDStarkey Laboratories, Inc.1994-07-05340
K942036EUROSTAR SUPER, EUROSTAR VFCStarkey Laboratories, Inc.1994-06-24570
K932269PRO-CONNECTStarkey Laboratories, Inc.1994-05-133670
K935701VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229Starkey Laboratories, Inc.1994-05-101610
K941636MINI PAKStarkey Laboratories, Inc.1994-05-04300
K940978STARKEY EUROLINE A SERIESStarkey Laboratories, Inc.1994-05-04640
K941635INTRA S, INTRA SHStarkey Laboratories, Inc.1994-05-04300
K934417OMNI 2000 SERIES ITC HEARING AIDStarkey Laboratories, Inc.1993-11-29770
K934416OMNI 2000 SERIES ITE HEARING AIDStarkey Laboratories, Inc.1993-11-29770
K933988BOSCH EUROSTARStarkey Laboratories, Inc.1993-10-07510
K933407STARKEY TYMPANETTE HEARING AIDStarkey Laboratories, Inc.1993-10-07870
K933989RESOLUTION ITC HEARING AIDStarkey Laboratories, Inc.1993-10-07510
K933113STARKEY TRILOGY II PROGRAMMABLE HEARING AIDStarkey Laboratories, Inc.1993-07-27320
K930805CE-9 IN-THE-EAR HEARING AIDStarkey Laboratories, Inc.1993-03-18300
K930853INTRA V AND SECRET EAR IIIStarkey Laboratories, Inc.1993-03-18280
K922752STARKEY LABORATORIES OTOSCOPEStarkey Laboratories, Inc.1992-09-04880
K923784STARKEY SM SERIES BTE HEARING AIDSStarkey Laboratories, Inc.1992-08-26290
K911579STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELSStarkey Laboratories, Inc.1991-05-07350
K903145HEARSET TELEPHONE HEARING SYSTEMStarkey Laboratories, Inc.1990-12-211560
K901833CE-8 CUSTOM IN-THE-EAR HEARING AIDSStarkey Laboratories, Inc.1990-08-091070
K902068HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETERStarkey Laboratories, Inc.1990-08-06910
K901860INTRA III AND INTRA IV HEARING AIDSStarkey Laboratories, Inc.1990-07-20870
K880969STAR 22,33,66 SERIES & STARKEY H. AND SM SERIESStarkey Laboratories, Inc.1988-04-11340
K880335INTRA II SECRET EAR HEARING AIDS ISEStarkey Laboratories, Inc.1988-03-18520
K880333CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7Starkey Laboratories, Inc.1988-03-18520
K880334CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7Starkey Laboratories, Inc.1988-03-18520
K873031STARKEY MODEL P1 MODULEStarkey Laboratories, Inc.1988-02-081880
K844275STARKET MODEL HMSStarkey Laboratories, Inc.1984-12-03280
K821908STARKEY MODEL HAL-1Starkey Laboratories, Inc.1982-08-03360
K802560TINNITUS RESEARCH AUDIOMETERStarkey Laboratories, Inc.1980-11-12270
K792214MODEL TM2-BEHIND-THE-EAR TINNITUSStarkey Laboratories, Inc.1979-11-27250
K791790MODEL TM5 BEHIND EAR TINNITUS MASKERStarkey Laboratories, Inc.1979-10-26450
K791142HEARING AID, MODEL MA-1Starkey Laboratories, Inc.1979-09-281020

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda