510(k) · Cleared
ClearedMS-Iii Ministim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life-Tech Intl., Inc. · BXN Stimulator, Nerve, Battery-Powered
Cleared on Oct 7, 1991 after an 81-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 7, 1991
- Review
- 81 days
- Class
- Class II
- Product code
- BXN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK913184 MS-Iii MinistimLife-Tech Intl., Inc. · 1991
- Descendant · cites it directly · 1 of its ownK121743 Easymed Peripheral Nerve Stimulator-SunstinSunmed, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK153045 SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve…Easy Med Instrument Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK143095 MiniStim MS-IVB Peripheral Nerve StimulatorHalyard Health, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K121743Easymed Peripheral Nerve Stimulator-SunstinSunmed, LLC · 2013 · cites it directly1descendant
- K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd. · 2016 · 2 generations on0descendants
- K143095MiniStim MS-IVB Peripheral Nerve StimulatorHalyard Health, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913184 | MS-Iii Ministim | Life-Tech Intl., Inc. | 1991 | — |
| +1 | K121743 | Easymed Peripheral Nerve Stimulator-Sunstin | Sunmed, LLC | 2013 | — |
| +2 | K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | Easy Med Instrument Co., Ltd. | 2016 | — |
| +1 | K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BXN? 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 BXN device
- #1 K213049 STIMPOD NMS450 Nerve Stimulatorscore 5.4 · 5 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K121743 (Sunmed, LLC, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BXN devicesBXN Stimulator, Nerve, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BXN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · BXN
108in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BXN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BXN
4in 2024
MAUDE reports naming product code BXN, 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 | 3 | 108 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K913184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913184: MS-Iii Ministim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913184
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026