510(k) · Cleared
ClearedStimuplex HNS-11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stockert GmbH · BXN Stimulator, Nerve, Battery-Powered
Cleared on Jun 6, 2001 after a 162-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jun 6, 2001
- Review
- 162 days
- Class
- Class II
- Product code
- BXN
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK003983 Stimuplex HNS-11Stockert GmbH · 2001
- Descendant · cites it directly · 15 of its ownK052313 Stimuplex HNS-12, Model 4892098Stockert GmbH · 2005
- Descendant · 2 generations on · 12 of its ownK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- Descendant · 2 generations on · 10 of its ownK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- Descendant · 3 generations on · 6 of its ownK102084 Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010
- Descendant · 4 generations on · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K052313Stimuplex HNS-12, Model 4892098Stockert GmbH · 2005 · cites it directly15descendants
- K072092Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007 · 2 generations on12descendants
- K093591Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009 · 2 generations on10descendants
- K102084Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010 · 3 generations on6descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003983 | Stimuplex HNS-11 | Stockert GmbH | 2001 | — |
| +1 | K052313 | Stimuplex HNS-12, Model 4892098 | Stockert GmbH | 2005 | — |
| +2 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| +2 | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| +3 | K102084 | Stimpod NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2010 | — |
| +4 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052313 | Stimuplex HNS-12, Model 4892098 | 2005 | 15 |
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, K052313 (Stockert GmbH, 2005) has gone furthest, with 15 descendants 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/K003983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003983: Stimuplex HNS-11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003983
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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