# K061983: Stimuplex Pen

- Pathway: 510(k) (Abbreviated)
- Applicant: Stockert GmbH
- Decided: Nov 21, 2006 after 131 days
- Product code: BXN (Stimulator, Nerve, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882438 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023342: Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii Nerve Mapping Probe, Neuro-Trace Iii Nerve BG, Hdc Corp. (2004) Summary page 1.

## Indications for use
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).

Source page: https://510kreport.com/device/K061983
Methodology: https://510kreport.com/methodology