510(k) · Cleared
ClearedStimuplex Pen
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 21, 2006 as substantially equivalent to K023342 (Hdc Corp., 2004) after a 131-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Nov 21, 2006
- Review
- 131 days
- Class
- Class II
- Product code
- BXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882438 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882438 | Constant Current Peripheral Nerve Stim. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988 | — |
| −1 | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii… | Hdc Corp. | 2004 | — |
| 0 (this device) | K061983 | Stimuplex Pen | Stockert GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping…Summary page 1…21 CFR 882.1320 Predicate Device: Nerve Mapping Probe (accessory only) for NeuroTrace III Nerve Stimulator K023342 Superficial nerves can be stimulated electrically through the skin by means of a weak current. Cutaneous electrical nerve stimul… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- None of the 5 ancestors has a recall.
- 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.
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® Pen is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, local/regional analgesia and neurology. It is a non invasive device.
Intended patient population: for adult, pediatric and/or infant use.
Stimuplex® Pen is intended to be used only with B.Braun's nerve stimulators: Stimuplex® HNS 11 (510k no. K003983) and/or Stimuplex® HNS 12 (510k no. K052313).
It can be used wherever peripheral anesthesia is normally applied (i.e. physician's office or hospital).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061983 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061983: Stimuplex Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061983
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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