510(k) · Cleared
ClearedAcustim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.H.P. Intl. Pty., Ltd. · BWK Stimulator, Electro-Acupuncture
Cleared on Jun 12, 2002 as substantially equivalent to K954334 (S.H.P. Intl. Pty., Ltd., 1996) after a 167-day review. Its family tree reaches back 1 generation to 1996. 13 later devices descend from it.
- Decided
- Jun 12, 2002
- Review
- 167 days
- Class
- Class U
- Product code
- BWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954334 (1996). 13 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954334 AcuplusS.H.P. Intl. Pty., Ltd. · 1996
- This deviceK014273 AcustimS.H.P. Intl. Pty., Ltd. · 2002
- Descendant · cites it directly · 9 of its ownK051197 Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK081943 Model ES-130Ito Co., Ltd. · 2008
- Descendant · 3 generations on · 3 of its ownK130768 Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013
- Descendant · 4 generations on · 2 of its ownK202861 Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK050123 P-Stim SystemNeuroscience Therapy Corp. · 2006
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K051197Aculife, Model SMW-01Inno-Health Technology, Inc. · 2006 · cites it directly9descendants
- K081943Model ES-130Ito Co., Ltd. · 2008 · 2 generations on7descendants
- K130768Jiajian CMN StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2013 · 3 generations on3descendants
- K202861Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd. · 2021 · 4 generations on2descendants
- K050123P-Stim SystemNeuroscience Therapy Corp. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954334 | Acuplus | S.H.P. Intl. Pty., Ltd. | 1996 | — |
| 0 (this device) | K014273 | Acustim | S.H.P. Intl. Pty., Ltd. | 2002 | — |
| +1 | K051197 | Aculife, Model SMW-01 | Inno-Health Technology, Inc. | 2006 | — |
| +2 | K081943 | Model ES-130 | Ito Co., Ltd. | 2008 | — |
| +3 | K130768 | Jiajian CMN Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013 | — |
| +4 | K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021 | — |
| +1 | K050123 | P-Stim System | Neuroscience Therapy Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 K244030 Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)score 10.6 · 6 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 |
|---|---|---|---|
| * | K954334 | AcuplusSummary page 4…stimulator. Classification name: Transcutaneous electrical nerve stimulator, Class II, 882.5890. Legally marketed device for substantial equivalence comparison: ACUPLUS K954 334. EELIET o Description of the Device: The device consists of a battery powered portable instrument, with a basic power pack whic… | 1996 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K051197 (Inno-Health Technology, Inc., 2006) has gone furthest, with 9 descendants of its own.
How does its category compare?
All BWK devicesBWK Stimulator, Electro-Acupuncture: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Etg, |ugtEended use of tho ACUSTIM is for use as an ELECTRO-ACUPUNCTURE
it can be used by a Physician administering to his patients,.or by a patient.
it is a prescription device and should be used under continued medical supervision.
it ick:;as not have curative value but stimulates appropriate auricular acupuncture poin
it cannot be used transcerebrally, in the carotid sinus area or during pnegdancy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014273 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014273: Acustim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026