Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPI — Predicate Candidate Screening
96 FDA 510(k) clearances under this product code; the 50 most recent screened below.
152 daysmedian FDA review time
304 days90th percentile
96clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026-06-18 | 148 | 0 |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A- | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-05-14 | 269 | 0 |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD | Shenzhen Changkun Technology Co., Ltd. | 2026-05-06 | 266 | 0 |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 2026-04-28 | 235 | 0 |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWE | Pontemedag | 2026-04-17 | 263 | 0 |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. | 2026-02-12 | 248 | 0 |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions | 2025-08-29 | 149 | 0 |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. | 2025-06-26 | 269 | 0 |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. | 2025-03-27 | 273 | 0 |
| K241516 | BTL-398 | BTL Industries, Inc. | 2025-02-10 | 257 | 0 |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | 2024-11-27 | 152 | 0 |
| K234061 | StarFormer | Fotona D.O.O. | 2024-07-01 | 192 | 0 |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM | Shenzhen Konmed Technology Co., Ltd. | 2024-02-23 | 108 | 0 |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile) | Zmi Electronics , Ltd. | 2024-01-18 | 268 | 0 |
| K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023-10-20 | 197 | 0 |
| K230780 | MFG-05 | Zimmer Medizinsysteme GmbH | 2023-10-05 | 197 | 0 |
| K230767 | Pelvic Floor Muscle Stimulator | Nanjing Vishee Medical Technology Co., Ltd. | 2023-09-21 | 185 | 0 |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: | Well-Life Healthcare Limited | 2022-12-29 | 129 | 0 |
| K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2022-07-20 | 181 | 0 |
| K213133 | Keffort (MC-100, MC-100A) | Oriental Inspiration Limited | 2022-04-13 | 198 | 0 |
| K213116 | Everyway Incontinence Stimulation System | Everyway Medical Instruments Co.,Ltd | 2021-12-03 | 67 | 0 |
| K210441 | Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-09-17 | 217 | 0 |
| K201014 | MyOnyx System | Thought Technology , Ltd. | 2021-01-13 | 271 | 0 |
| K200293 | InMode System with vTone Applicator | InMode , Ltd. | 2020-05-05 | 90 | 0 |
| K191312 | Perfect PFE | Tenscare, Ltd. | 2019-11-01 | 170 | 0 |
| K182022 | ApexMV | Incontrol Medical, LLC | 2019-03-15 | 231 | 0 |
| K181497 | HPM-6000UF | BTL Industries, Inc. | 2018-11-14 | 160 | 0 |
| K171430 | Incontinence Treatment Device, Model LT2061 | Shenzhen Dongdixin Technology Co., Ltd. | 2018-03-15 | 304 | 0 |
| K163288 | Pelvifine Pelvic Muscle Trainer | Shenzhen Konmed Technology Co., Ltd. | 2018-01-18 | 422 | 0 |
| K161349 | Everyway Incontinence Stimulation System | Everyway Medical Instrument Co., Ltd. | 2017-07-07 | 417 | 0 |
| K162010 | HPM-6000U | BTL Industries, Inc. | 2016-12-13 | 146 | 0 |
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuj | Fuji Dynamics , Ltd. | 2016-07-12 | 89 | 0 |
| K160773 | Yarlap II | International Trade Group, Inc. | 2016-05-04 | 44 | 0 |
| K142369 | Urinary Incontinence System | Guangzhou Finecure Medical Equipment Co.,Ltd | 2015-06-17 | 296 | 0 |
| K141643 | YARLAP | International Trade Group, Inc. | 2015-04-24 | 309 | 0 |
| K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015-04-20 | 224 | 0 |
| K150183 | ApexM | Incontrol Medical, LLC | 2015-04-09 | 72 | 0 |
| K150180 | InTone | Incontrol Medical, LLC | 2015-03-16 | 48 | 0 |
| K140265 | ELECTRODE FOR URINARY INCONTINENCE | Guangzhou Finecure Medical Equipment Co.,Ltd | 2015-01-23 | 354 | 0 |
| K141158 | APEX | Incontrol Medical, LLC | 2014-11-26 | 205 | 0 |
| K134020 | INTONEMV | Incontrol Medical, LLC | 2014-02-25 | 57 | 0 |
| K133826 | INTONEMV | Incontrol Medical, LLC | 2014-01-06 | 20 | 0 |
| K122194 | LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE | Everyway Medical Instruments Co.,Ltd | 2013-04-04 | 254 | 0 |
| K121820 | INWAVE | Zynex Medical, Inc. | 2012-08-24 | 64 | 0 |
| K110179 | INCONTROL | Incontrol Medical, LLC | 2012-02-22 | 397 | 0 |
| K103698 | TENSCARE ITOUCH SURE MODEL ITS | Tenscare, Ltd. | 2011-06-21 | 183 | 0 |
| K093600 | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM | Accelerated Care Plus | 2009-12-04 | 14 | 0 |
| K083704 | NUTRAC PELVATOR, MODEL PEL 200 | Verity Scientific , Ltd. | 2009-07-14 | 211 | 0 |
| K081480 | KEGEL8 PELVIC EXERCISER, MODEL OPH 400 | Ne Services , Ltd. | 2008-09-12 | 108 | 0 |
| K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | Laborie Medical Technologies | 2007-05-04 | 88 | 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