510(k) · Cleared
ClearedNeedle Stimulator (CMNS6-1 PLUS, CMNS6-3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuxi Jiajian Medical Instrument Co., Ltd. · BWK Stimulator, Electro-Acupuncture
Cleared on Mar 28, 2025 as substantially equivalent to K202861 (Wuxi Jiajian Medical Instrument Co., Ltd., 2021) after an 88-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Mar 28, 2025
- Review
- 88 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954334 (1996). 7 ancestors in all, the oldest K840983 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK954334 AcuplusS.H.P. Intl. Pty., Ltd. · 1996
- 5 generations backK014273 AcustimS.H.P. Intl. Pty., Ltd. · 2002
- 4 generations backK051197 Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006
- 3 generations backK081943 Model ES-130Ito Co., Ltd. · 2008
- 2 generations backK130768 Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013
- 1 generation backK202861 Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
- This deviceK244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954334 | Acuplus | S.H.P. Intl. Pty., Ltd. | 1996 | — |
| −5 | K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | 2002 | — |
| −4 | K051197 | Aculife, Model SMW-01 | Inno-Health Technology, Inc. | 2006 | — |
| −3 | K081943 | Model ES-130 | Ito Co., Ltd. | 2008 | — |
| −2 | K130768 | Jiajian CMN Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013 | — |
| −1 | K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
| 0 (this device) | K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BWK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BWK device
- #1 K202861 Needle Stimulatorscore 9.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202861 | Needle StimulatorSummary page 5…by qualified practitioners of acupuncture as determined by the states. 3. Predicate Device Identification Predicate 510(k) Number: K202861 Marketing Clearance Date: 08/27/2021 Product Name: Needle Stimulator Manufacturer: Wuxi… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K202861.
How does its category compare?
All BWK devicesBWK Stimulator, Electro-Acupuncture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BWK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWK
212in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWK
No recall names BWK since 2007.
Adverse event reports per year · BWK
1in 2024
MAUDE reports naming product code BWK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 212 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244030: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244030
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026