# K070134: Modification to Stimuplex HNS-12, Model 4892098

- Pathway: 510(k) (Special)
- Applicant: Stockert GmbH
- Decided: Mar 22, 2007 after 65 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 K003983 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052313: Stimuplex HNS-12, Model 4892098, Stockert GmbH (2005) Summary page 1.

## Indications for use
Stimuplex® HNS 12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anaesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anaesthetics. This device can be used wherever peripheral anaesthesia is normally applied (i.e. physicians office or hospital). Intended patient population: for adult, pediatric and/or infant use.

Source page: https://510kreport.com/device/K070134
Methodology: https://510kreport.com/methodology