510(k) · Cleared
ClearedEasymed Peripheral Nerve Stimulator-Sunstin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunmed, LLC · BXN Stimulator, Nerve, Battery-Powered
Cleared on Mar 28, 2013 as substantially equivalent to K913184 (Life-Tech Intl., Inc., 1991) after a 288-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Mar 28, 2013
- Review
- 288 days
- Class
- Class II
- Product code
- BXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913184 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK913184 MS-Iii MinistimLife-Tech Intl., Inc. · 1991
- This deviceK121743 Easymed Peripheral Nerve Stimulator-SunstinSunmed, LLC · 2013
- Descendant · cites it directly · 0 of its ownK153045 SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve…Easy Med Instrument Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913184 | MS-Iii Ministim | Life-Tech Intl., Inc. | 1991 | — |
| 0 (this device) | K121743 | Easymed Peripheral Nerve Stimulator-Sunstin | Sunmed, LLC | 2013 | — |
| +1 | K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | Easy Med Instrument Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K913184 | MS-Iii MinistimSummary page 2…=== IDENTIFICATION OF PREDICATE DEVICE Company Device 510k No. Life-Tech Intl., Inc. MiniStimn K913 184 DEVICE DESCRIPTION The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which prov… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | 2016 | 0 |
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?
How does its category compare?
All BXN devicesBXN Stimulator, Nerve, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Ile EasyMed InsrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks imgeneral anesthesia, by delivering an electrical stimulus nar a peripheral motor nerve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121743: Easymed Peripheral Nerve Stimulator-Sunstin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121743
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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