510(k) · Cleared
ClearedStimpod Model NMS-400 Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xavant Technology (Pty), Ltd. · BXN Stimulator, Nerve, Battery-Powered
Cleared on Dec 3, 2009 as substantially equivalent to K023342 (Hdc Corp., 2004) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1988. 10 later devices descend from it.
- Decided
- Dec 3, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- BXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K882438 (1988). 8 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK882438 Constant Current Peripheral Nerve Stim. #NS252Fisher & Paykel Healthcare, Ltd. · 1988
- 2 generations backK023342 Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable…Hdc Corp. · 2004
- 1 generation backK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- This deviceK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- Descendant · cites it directly · 6 of its ownK102084 Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010
- Descendant · 2 generations on · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · cites it directly · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K102084Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010 · cites it directly6descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · 2 generations on2descendants
- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · cites it directly2descendants
- K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025 · 3 generations on1descendant
- K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882438 | Constant Current Peripheral Nerve Stim. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988 | — |
| −2 | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii… | Hdc Corp. | 2004 | — |
| −1 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| 0 (this device) | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| +1 | K102084 | Stimpod NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2010 | — |
| +2 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +1 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| +3 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +4 | K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006)… | Neuralytix | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 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), 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? (3)
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 |
|---|---|---|---|
| * | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping…Summary page 2…PREDICATE DEVICES - HDC Corporation, NeuroTrace Ill (K023342) Xavant Technology, XPOD/XMAP Nerve Stimulator (K072092)… | 2004 |
| * | K072092 | Xpod/Xmap Nerve StimulatorSummary page 2…Ill (K023342) Xavant Technology, XPOD/XMAP Nerve Stimulator (K072092) Stockert GmbH, Stimuplex HNS12 (K05231 3) Ther… | 2007 |
| * | K052313 | Stimuplex HNS-12, Model 4892098Summary page 2…ulator (K072092) Stockert GmbH, Stimuplex HNS12 (K05231 3) There are no significant differences between the STIMPOD NMS400 Nerve Stimulator and the predicate devices that would adversel… | 2005 |
What descends from it? (10)
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K102084 (Xavant Technology (Pty), Ltd., 2010) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K023342.
How does its category compare?
All BXN devicesBXN Stimulator, Nerve, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of
1. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
2. nerve locating using invasive electrodes/needles (not suiiplied)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093591: Stimpod Model NMS-400 Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093591
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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