Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IMI — Predicate Candidate Screening
89 FDA 510(k) clearances under this product code; the 50 most recent screened below.
121 daysmedian FDA review time
337 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025-06-04 | 439 | 0 |
| K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | 2023-10-24 | 244 | 0 |
| K222098 | ManaSport+ | Manamed, Inc. | 2023-03-08 | 233 | 0 |
| K210284 | ManaSport | Manamed, Inc. | 2022-04-26 | 448 | 0 |
| K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | 2021-12-23 | 457 | 0 |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (C | Brh Medical , Ltd. | 2017-08-25 | 562 | 0 |
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016-11-10 | 150 | 0 |
| K160075 | Accent XL | Alma Lasers, Inc. | 2016-08-17 | 216 | 0 |
| K161502 | MC1 Plus | General Project S.R.L. | 2016-08-16 | 76 | 0 |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | 2015-08-26 | 316 | 0 |
| K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | Ibramed Equipamentos Medicos | 2014-01-27 | 265 | 0 |
| K130888 | SONOPULSE/ SONOPULSE III | Ibramed- Industria Brazileria DE Equipamentos Medi | 2014-01-09 | 286 | 0 |
| K124010 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2013-08-23 | 239 | 0 |
| K120171 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2012-05-04 | 105 | 0 |
| K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011-10-26 | 56 | 0 |
| K091615 | MED CONTOUR | General Project S.R.L. | 2010-05-06 | 337 | 0 |
| K090542 | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, | Sun-Rain System Corp. | 2009-10-23 | 235 | 0 |
| K062256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED | Hill Laboratories Co. | 2007-02-26 | 206 | 0 |
| K053041 | MED SCULPT | General Project S.R.L. | 2006-08-02 | 279 | 0 |
| K052934 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | S.O.R. Internacional, S.A. | 2006-06-12 | 236 | 0 |
| K053546 | SONICATOR 740, MODEL ME 740 | Mettler Electronics Corp. | 2006-05-04 | 135 | 0 |
| K050410 | HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3 | Hwang Sun Enterprise Co., Ltd. | 2005-07-14 | 147 | 0 |
| K040798 | HES ULTRASONIC THERAPY APPLIANCE | Hwang Sun Enterprise Co., Ltd. | 2004-08-04 | 128 | 0 |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Chattanooga Group | 2003-12-03 | 239 | 1 |
| K024013 | SUN-RAIN ULTRASONIC THERAPY, SU-100 | Sun-Rain System Corp. | 2003-10-31 | 331 | 0 |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFR | Dynatronics Corp. | 2003-10-22 | 177 | 0 |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Ito Co., Ltd. | 2003-10-09 | 30 | 0 |
| K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Sybaritic, Inc. | 2003-07-02 | 190 | 1 |
| K030878 | ACCOUSONIC, MODEL AS-270 | Metron Medical Australia, Pty, Ltd. | 2003-03-28 | 8 | 0 |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | Metron Medical Australia, Pty, Ltd. | 2003-02-20 | 13 | 0 |
| K021483 | RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND | Rich-Mar Corp. | 2002-09-13 | 128 | 0 |
| K013192 | SONICATOR PLUS 930, MODEL ME 930 | Mettler Electronics Corp. | 2001-10-17 | 22 | 0 |
| K010702 | XUB EXTERNAL ULTRASOUND | Kmi Kolster Methods, Inc. | 2001-08-09 | 154 | 0 |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | 2001-07-16 | 24 | 0 |
| K010609 | ACCUSONIC, MODEL AS-260 | Metron Medical Australia, Pty, Ltd. | 2001-03-16 | 15 | 0 |
| K010102 | SONIC MODEL SO-300 | Metron Medical Australia, Pty, Ltd. | 2001-02-09 | 28 | 0 |
| K991613 | SW ULTRASOUND, MODELS 331, 311, 333 | Starbene | 2000-12-08 | 578 | 0 |
| K000084 | ENRAF-NONIUS SONOPULS 190 SYSTEM | Henley Healthcare, Inc. | 2000-08-04 | 205 | 0 |
| K000593 | SONIC, MODEL SO-100 | Metron Medical Australia, Pty, Ltd. | 2000-08-04 | 164 | 0 |
| K001370 | ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | 2000-07-17 | 77 | 0 |
| K000604 | NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRAS | Naturopathic Laboratories International, Inc. | 2000-05-23 | 90 | 0 |
| K984199 | EXONIX | Fibra Sonics, Inc. | 1999-02-17 | 85 | 0 |
| K981449 | SD-956 ULTRASOUND THERAPY | Skylark Device Co., Ltd. | 1998-12-11 | 233 | 0 |
| K982544 | RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICE | Rich-Mar Corp. | 1998-11-19 | 121 | 0 |
| K982829 | FORTE, MODEL CPS ULTRASOUND | Chattanooga Group, Inc. | 1998-11-06 | 87 | 0 |
| K973024 | INTELECT LEGEND ULTRASOUND | Chattanooga Group, Inc. | 1997-11-10 | 88 | 0 |
| K970131 | ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE | C.L. Mcintosh & Assoc., Inc. | 1997-06-16 | 153 | 0 |
| K961250 | DYNATRON 125 ULTRASOUND | Dynatronics Corp. | 1996-08-26 | 147 | 0 |
| K960802 | CUSHMAN MANUFACTURING, INC. ULTRA 6.0. | Cushman Mfg., Inc. | 1996-06-18 | 112 | 0 |
| K954136 | MATRIX MICROSON 410 | Matrix Biokinetics, Inc. | 1996-04-01 | 213 | 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