# K860126: Stimuplex, Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Burron Medical Products, Inc.
- Decided: Feb 28, 1986 after 45 days
- Product code: BXN (Stimulator, Nerve, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 17, 2024 · Class II · Z-2132-2024: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- May 17, 2024 · Class II · Z-2133-2024: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- May 17, 2024 · Class II · Z-2131-2024: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- May 17, 2024 · Class II · Z-2134-2024: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Source page: https://510kreport.com/device/K860126
Methodology: https://510kreport.com/methodology