Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IMG — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
302 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-10-07 | 281 | 0 |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Pro | Accelerated Care Plus (Acp) | 2016-08-26 | 256 | 0 |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 | 267 | 0 |
| K150353 | BTL-4000 | BTL Industries, Inc. | 2015-11-13 | 275 | 0 |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 | 302 | 0 |
| K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | Zimmer Medizinsystems GmbH | 2012-08-07 | 123 | 0 |
| K102524 | FUTURA | Dr. Oliver Wenker, M.D., M.B.A. | 2011-11-03 | 427 | 0 |
| K111482 | SONICATOR PLUS 920 | Mettler Electronics Corp. | 2011-08-25 | 90 | 0 |
| K102190 | WINSTIM | Johari Digital Healthcare , Ltd. | 2011-03-17 | 226 | 0 |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 | 141 | 0 |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Mettler Electronics Corp. | 2007-08-01 | 99 | 0 |
| K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Alfa Tech Medical Systems, Ltd. | 2007-04-04 | 110 | 0 |
| K063135 | SONIC-STIM | Naimco, Inc. | 2007-02-05 | 112 | 0 |
| K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATO | Alfa Tech Medical Systems, Ltd. | 2005-12-09 | 105 | 0 |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS) | Chattanooga Group | 2004-04-12 | 66 | 1 |
| K040121 | DERMAWAVE 5000 COMBI MAX SYSTEM | Dermawave, LLC | 2004-03-17 | 57 | 0 |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Chattanooga Group | 2003-12-11 | 251 | 17 |
| K030880 | VECTORSONIC, MODEL VU-270 | Metron Medical Australia, Pty, Ltd. | 2003-04-18 | 29 | 0 |
| K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT | Reliant Technologies, Inc. | 2003-02-14 | 154 | 0 |
| K020119 | VECTORSONIC, MODEL VU-200 | Metron Medical Australia, Pty, Ltd. | 2002-07-22 | 189 | 0 |
| K001166 | ULTRA V THERAPEUTIC ULTRASOUND | Excel Tech. , Ltd. | 2000-07-07 | 88 | 0 |
| K982317 | VECTRA COMBO | Chattanooga Group, Inc. | 1999-02-01 | 214 | 0 |
| K982830 | FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO | Chattanooga Group, Inc. | 1998-11-06 | 87 | 0 |
| K953614 | FORTE | Chattanooga Group, Inc. | 1995-10-27 | 85 | 0 |
| K951746 | FORTE CB | Chattanooga Group, Inc. | 1995-06-21 | 97 | 0 |
| K943469 | SONICATOR 730 | Mettler Electronics Corp. | 1994-08-29 | 41 | 0 |
| K941561 | FORTE US | Chattanooga Group, Inc. | 1994-06-20 | 80 | 0 |
| K935728 | DYNATRON 150 | Dynatronics Corp. | 1994-04-26 | 146 | 0 |
| K940180 | FORTE US | Chattanooga Group, Inc. | 1994-04-15 | 93 | 0 |
| K934287 | DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR | Dynawave, Corp. | 1994-04-04 | 214 | 0 |
| K934846 | SONICATOR 716 | Mettler Electronics Corp. | 1994-03-23 | 166 | 0 |
| K935271 | THERAPEUTIC ULTRASOUND AND STIMULATOR | Chattanooga Group, Inc. | 1994-02-02 | 92 | 0 |
| K934845 | SONICATOR 715 | Mettler Electronics Corp. | 1994-01-21 | 105 | 0 |
| K932937 | DYNATRON 800 | Dynatronics Corp. | 1993-10-08 | 114 | 0 |
| K922036 | SONOPULS 591 | Henley Intl. | 1993-06-29 | 424 | 0 |
| K921436 | SONICATOR PLUS | Mettler Electronics Corp. | 1993-04-27 | 398 | 0 |
| K921952 | ULTRA III | Excel Tech. , Ltd. | 1993-03-09 | 316 | 0 |
| K920939 | DYNATRON 300 ULRASOUND | Dynatronics Laser Corp. | 1993-03-04 | 371 | 0 |
| K923797 | MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED | Rich-Mar Corp. | 1992-11-06 | 101 | 0 |
| K911733 | INTELECT, MODEL 245 | Chattanooga Group, Inc. | 1991-12-17 | 244 | 0 |
| K902875 | INTELECT 750 MP | Chattanooga Group, Inc. | 1990-09-27 | 87 | 0 |
| K902860 | INTELECT 170 | Chattanooga Group, Inc. | 1990-09-27 | 90 | 0 |
| K900189 | CURAPULS 403 DIATHERMY UNIT | Henley Intl. | 1990-09-18 | 245 | 0 |
| K895690 | ULTRA (THERAPEUTIC ULTRASOUND DEVICE) | Excel Tech. , Ltd. | 1990-02-20 | 151 | 0 |
| K883893 | OMNISOUND(TM) 3000 | Physio Technology, Inc. | 1988-11-01 | 48 | 0 |
| K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION | Elmed, Inc. | 1988-01-13 | 173 | 0 |
| K872394 | SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT | Henley Intl. | 1987-09-03 | 83 | 0 |
| K871647 | STIMULATOR, ULTRASOUND AND MUSCLE | Amy West | 1987-06-29 | 62 | 0 |
| K861837 | FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND | Fischer Industries, Inc. | 1986-08-07 | 86 | 0 |
| K844217 | RICH-MAR DELTA 330 HV | Rich-Mar Corp. | 1984-11-27 | 27 | 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