Atlas FDA

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

Electone, Inc. — Predicate Candidate Screening

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

53 daysmedian FDA review time
118 days90th percentile
73clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973266Z DEQ-IIElectone, Inc.1997-09-23250
K961084AM 400Electone, Inc.1996-04-18300
K955702SONATA U-01Electone, Inc.1996-02-22690
K953047Z20Electone, Inc.1995-08-22530
K953050Z33Electone, Inc.1995-08-22530
K953051Z35Electone, Inc.1995-08-15460
K953052AM 260 K-AMPElectone, Inc.1995-08-15460
K953048Z22Electone, Inc.1995-08-15460
K953054AM 260 OHMElectone, Inc.1995-08-15460
K953049Z24Electone, Inc.1995-08-15460
K953053AM 260 PPElectone, Inc.1995-08-15460
K951642GOLD CD ULTRA MINI CANAL - MODULEElectone, Inc.1995-07-11920
K950458SILVER ULTRA MINI CANALElectone, Inc.1995-03-31560
K950460GOLD CD ULTRA MINI CANALElectone, Inc.1995-03-24490
K950459GOLD K AMP ULTRA MINI CANALElectone, Inc.1995-03-24490
K942722MODULE PROGRAMElectone, Inc.1994-09-06890
K941133770-ATCElectone, Inc.1994-05-12640
K933038GOLD AF MODULE, ITEElectone, Inc.1993-08-02960
K933042SILVER COMPRESSION 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
K933041COLD CD ASP MODULE, ITEElectone, Inc.1993-08-02960
K933036GOLD ASP 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
K922501M30 IN THE EAR HEARING AIDElectone, Inc.1993-06-243930
K922502M32 IN THE EAR HEARING AIDElectone, Inc.1993-06-243930
K924888P54 HEARING AIDElectone, Inc.1992-11-24570
K924887P54-0 BEHIND THE EAR HEARING AIDElectone, Inc.1992-11-24570
K914948AM 300 AGC-OElectone, Inc.1992-02-191070
K914798PREMIER CLASS D-ASPElectone, Inc.1992-02-181180
K914799PREMIER K-AMPElectone, Inc.1992-02-181180
K914796PREMIER ASP/CD RECHARGEABLEElectone, Inc.1992-02-181180
K914947AM 300 XPElectone, Inc.1992-02-181060
K914795ELECTONE/PA RECHARGEABLEElectone, Inc.1992-02-181180
K914797PREMIER CD RECHARGEABLEElectone, Inc.1992-02-181180
K911705CHAMPION, BEHIND-THE-EAR HEARING AIDElectone, Inc.1991-05-17310
K911709STOCK CANAL, IN-THE-EAR HEARING AIDElectone, Inc.1991-05-17310
K911706MODEL 800, BEHIND-THE-EAR HEARING AIDElectone, Inc.1991-05-17310
K911707REGAL, BEHIND-THE-EAR HEARING AIDElectone, Inc.1991-05-17310
K911708MODEL E-50, IN-THE-EAR HEARING AIDElectone, Inc.1991-05-17310
K910097ELECTONE ITE MODEL PREMIERElectone, Inc.1991-04-03840
K910148AM130 AGC-O (BEHIND THE EAR) HEARING AIDElectone, Inc.1991-01-29150
K910101ELECTONE BTE MODEL AM 130 PPElectone, Inc.1991-01-29200
K910099ELECTONE BTE MODEL AM 240 HFElectone, Inc.1991-01-29200
K910100ELECTONE BTE MODEL AM 130 DElectone, Inc.1991-01-29200
K910102ELECTONE BTE MODEL AM 240 PPLElectone, Inc.1991-01-29200

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