Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BWK — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
188 daysmedian FDA review time
333 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 | 88 | 0 |
| K220153 | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-03-18 | 58 | 0 |
| K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-08-27 | 333 | 0 |
| K200636 | AXUS ES-5 Electro-Acupuncture Device | Lhasa Oms, Inc. | 2021-02-03 | 330 | 0 |
| K170391 | ANSiStim-PP | Dyansys, Inc. | 2017-03-09 | 29 | 0 |
| K152571 | Stivax | Biegler GmbH | 2016-05-26 | 260 | 0 |
| K141168 | ANSISTIM | Dyansys, Inc. | 2015-05-15 | 374 | 0 |
| K133980 | PANTHEON ELECTROSTIMULATOR | Pantheon Research | 2014-11-07 | 315 | 0 |
| K140530 | Electro Auricular Device | Navigant Consulting, Inc. | 2014-10-02 | 212 | 0 |
| K140788 | P-STIM | Biegler GmbH | 2014-06-27 | 88 | 0 |
| K130768 | JIAJIAN CMN STIMULATOR | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 | 149 | 0 |
| K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 | 210 | 0 |
| K093322 | MULTI-PURPOSE HEALTH DEVICE | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 | 286 | 0 |
| K091933 | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 | Inno-Health Technology, Inc. | 2010-04-02 | 276 | 0 |
| K091875 | E-PULSE | Medevice Corporation | 2009-12-07 | 167 | 0 |
| K081943 | MODEL ES-130 | Ito Co., Ltd. | 2008-11-24 | 139 | 0 |
| K050123 | P-STIM SYSTEM | Neuroscience Therapy Corp. | 2006-03-30 | 435 | 0 |
| K051197 | ACULIFE, MODEL SMW-01 | Inno-Health Technology, Inc. | 2006-03-28 | 322 | 0 |
| K014273 | ACUSTIM | S.H.P. Intl. Pty., Ltd. | 2002-06-12 | 167 | 0 |
| K840995 | ACUPUNCTURE INSOLES | Lu LU Enterprise Co. , Ltd. | 1984-03-27 | 19 | 0 |
| K840983 | PULSELIFE STIMULATOR | Pulse Life, Inc. | 1984-03-27 | 21 | 0 |
| K832634 | SELECTRODE SYSTEM | Bio-Stimu Trend Corp. | 1984-01-25 | 174 | 0 |
| K781651 | HEALTH POINT | Anritsu America Co. | 1979-04-03 | 188 | 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