# K153045: SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

- Pathway: 510(k) (Special)
- Applicant: Easy Med Instrument Co., Ltd.
- Decided: May 13, 2016 after 207 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 K913184 (1991). 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)
- K121743: Easymed Peripheral Nerve Stimulator-Sunstin, Sunmed, LLC (2013) Summary page 5.

## Indications for use
SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

Source page: https://510kreport.com/device/K153045
Methodology: https://510kreport.com/methodology