510(k) · Cleared
ClearedStimuplex HNS-12, Model 4892098
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 Nov 17, 2005 as substantially equivalent to K003983 (Stockert GmbH, 2001) after an 84-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it.
- Decided
- Nov 17, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- BXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003983 (2001). 15 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK003983 Stimuplex HNS-11Stockert GmbH · 2001
- This deviceK052313 Stimuplex HNS-12, Model 4892098Stockert GmbH · 2005
- Descendant · cites it directly · 12 of its ownK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- Descendant · cites it directly · 10 of its ownK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- Descendant · 2 generations on · 6 of its ownK102084 Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010
- Descendant · 3 generations on · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · 2 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K072092Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007 · cites it directly12descendants
- K093591Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009 · cites it directly10descendants
- K102084Stimpod NMS450 Nerve StimulatorXavant Technology (Pty), Ltd. · 2010 · 2 generations on6descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · 3 generations on2descendants
- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003983 | Stimuplex HNS-11 | Stockert GmbH | 2001 | — |
| 0 (this device) | K052313 | Stimuplex HNS-12, Model 4892098 | Stockert GmbH | 2005 | — |
| +1 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| +1 | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| +2 | K102084 | Stimpod NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2010 | — |
| +3 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +2 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K003983 | Stimuplex HNS-11Summary page 1…, Class II, 73 BXN Battery Powered Nerve Stimulator 21 CFR 868.2775 Predicate Device: Stimuplex® FINS 11 K003983 The nerve stimulator Stimuplex®D HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the… | 2001 |
What descends from it? (15)
See all 154 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, K072092 (Xavant Technology (Pty), Ltd., 2007) has gone furthest, with 12 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 | — |
What is it indicated for?
Stimuplex HNS-12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anesthetics. This device can be used wherever peripheral anesthesia is normally applied (i.e. physicians office or hospital).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052313: Stimuplex HNS-12, Model 4892098.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052313
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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