Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LRB — Predicate Candidate Screening

24 FDA 510(k) clearances under this product code; the 50 most recent screened below.

96 daysmedian FDA review time
188 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974219FACEPLATE ASSEMBLYFinetone Hearing Instruments1998-02-201020
K961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.1996-11-071970
K942722MODULE PROGRAMElectone, Inc.1994-09-06890
K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing Instrument1994-06-17390
K935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.1994-02-091110
K933038GOLD AF MODULE, ITEElectone, Inc.1993-08-02960
K933040GOLD CD MODULE, ITEElectone, Inc.1993-08-02960
K933045SILVER RECHARGEABLE MODULE, ITEElectone, Inc.1993-08-02960
K933046SILVER L MODULE, ITEElectone, Inc.1993-08-02960
K933043SILVER PPP MODULE, ITEElectone, Inc.1993-08-02960
K933039GOLD L MODULE, ITEElectone, Inc.1993-08-02960
K933037GOLD K AMP, ITEElectone, Inc.1993-08-02960
K933044SILVER LD MODULE, ITEElectone, Inc.1993-08-02960
K910901FACEPLATE ITE HEARING AID MODEL 28ATelex Communications, Inc.1991-05-30860
K910900FACEPLATE ITE HEARING AID MODEL TCATelex Communications, Inc.1991-05-30860
K897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AIDAudina Hearing Instrument1990-03-16870
K896304OLYMPIA FACEPLATE MODULEOlympia Instruments, Inc.1990-01-26880
K873031STARKEY MODEL P1 MODULEStarkey Laboratories, Inc.1988-02-081880
K872645AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCRRichards Medical Co., Inc.1987-12-081550
K873300SERVICE MASTER (IMPULSE)Richards Medical Co., Inc.1987-12-081120
K871884IN THE EAR & IN THE CANAL HEARING AID FACE PLATEHearing Services, Inc.1987-10-271670
K862769FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPRMaico Hearing Instruments, Inc.1986-08-13220
K862768FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10Maico Hearing Instruments, Inc.1986-08-13220
K834479RELIABLEReliable Hearing Aide1984-07-112040

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