Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EGJ — Predicate Candidate Screening
73 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
420 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | 2025-04-01 | 263 | 0 |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | 2024-10-17 | 164 | 0 |
| K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | 2023-10-16 | 101 | 0 |
| K192749 | Dermadry | Dermadry Laboratories, Inc. | 2020-02-10 | 133 | 0 |
| K191436 | Saalio | Saalmann Medical GmbH & Co. KG | 2019-10-18 | 141 | 0 |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, El | Hightech Development | 2018-06-15 | 452 | 0 |
| K170291 | IontoDC | Soterix Medical, Inc. | 2017-05-01 | 90 | 0 |
| K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | 2015-05-20 | 89 | 0 |
| K133033 | HIDREX PSP1000 | Hidrex GmbH | 2015-04-08 | 559 | 3 |
| K132832 | ACTIVAPATCH ET IONTOPHORESIS PATCH | Activatek, Inc. | 2014-02-13 | 156 | 0 |
| K110636 | TULA IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2011-06-16 | 104 | 0 |
| K083016 | ACTHYDERM | Microlab Americas, Inc. | 2009-06-16 | 250 | 0 |
| K091326 | ACTIVAPATCH | Activatek, Inc. | 2009-05-27 | 22 | 0 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELE | Axelgaard Mfg. Co., Ltd. | 2008-06-18 | 107 | 0 |
| K073276 | IONTOPHORESIS SYSTEM | Acclarent, Inc. | 2008-03-05 | 105 | 0 |
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | Empi | 2007-11-16 | 30 | 0 |
| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | Empi | 2007-05-14 | 90 | 0 |
| K061849 | MESODERM | Aa Advanced Technology, Inc. | 2007-04-30 | 304 | 0 |
| K062792 | ERCHONIA IOTO_240 | Erchonia Medical, Inc. | 2007-03-01 | 164 | 0 |
| K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | Iomed, Inc. | 2007-02-28 | 104 | 0 |
| K061522 | TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM | Activatek, Inc. | 2006-08-01 | 60 | 0 |
| K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | Dynatronics Corp. | 2006-06-14 | 79 | 0 |
| K060579 | COMFORT/IO IONTOPHORESIS ELECTRODES | Pepin Mfg., Inc. | 2006-04-20 | 45 | 0 |
| K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | Iomed, Inc. | 2006-03-31 | 60 | 0 |
| K052019 | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE | North Coast Medical, Inc. | 2005-11-04 | 101 | 0 |
| K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE | Dynatronics Corp. | 2005-01-07 | 64 | 0 |
| K042590 | TRANSDERM IONTO SYSTEM, MK 2 | Mattioli Engineering Corp. | 2004-10-14 | 21 | 0 |
| K041101 | MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELE | Medical Adhesiveonline, LLC | 2004-07-07 | 72 | 0 |
| K040495 | NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS | Naimco, Inc. | 2004-04-22 | 56 | 0 |
| K032968 | TRSANSDERM IONTO SYSTEM | Mattioli Engineering Corp. | 2003-12-02 | 70 | 0 |
| K031769 | E-STRIP | Eemso, Inc. | 2003-10-14 | 127 | 0 |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG D | Selectivemed Components, Inc. | 2003-05-20 | 48 | 1 |
| K022950 | MINIPHYSIONIZER 2.0 AND ELECTRODES | Physion, Inc. | 2003-04-18 | 225 | 0 |
| K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | Empi | 2003-04-08 | 62 | 0 |
| K020476 | MEDION 6000 | Selectivemed Components, Inc. | 2002-05-03 | 80 | 0 |
| K000574 | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRO | Wr Medical Electronics Co. | 2000-08-09 | 169 | 0 |
| K993081 | IO-DRIVE | Selectivemed Components, Inc. | 2000-03-03 | 170 | 0 |
| K992708 | IONTOPATCH | Birch Point Medical, Inc. | 2000-02-01 | 174 | 2 |
| K991991 | DUPEL IONTOPHORESIS SYSTEM | Empi | 1999-09-10 | 88 | 0 |
| K982668 | PHORESOR II,MODEL PM900 | Iomed, Inc. | 1999-03-02 | 214 | 0 |
| K983484 | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE | Empi | 1998-12-28 | 84 | 0 |
| K970491 | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES | Empi | 1997-05-30 | 109 | 0 |
| K964208 | MD-1A GALVANIC UNIT | R. A. Fischer Co. Corp. | 1997-04-30 | 208 | 0 |
| K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II | Skylark Device Co., Ltd. | 1995-12-20 | 356 | 0 |
| K935868 | DYNAPHOR(TM) TWO | Maxxim Medical | 1995-03-15 | 464 | 0 |
| K932621 | RH-801/GS MODEL TRANSQ(R)1 | Iomed, Inc. | 1994-07-26 | 420 | 0 |
| K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | Iomed, Inc. | 1994-07-26 | 322 | 0 |
| K932620 | RH-806/GS MODEL TRANSQ(R)2 | Iomed, Inc. | 1994-07-26 | 420 | 0 |
| K915444 | DUPEL IONTOPHORESIS DEVICE | Empi | 1994-07-15 | 953 | 0 |
| K913601 | MICROPHOR | Life-Tech Intl., Inc. | 1994-07-15 | 1067 | 0 |
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