# K112435: Rhythmlink Monopolar Stimulating Instrument

- Pathway: 510(k) (Special)
- Applicant: Rhythmlink International, LLC
- Decided: Sep 22, 2011 after 29 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K133348: Stim Probe (2014), 1 descendant of its own
- K152769: Fremap Electrode (2016), 0 descendants of its own

## Indications for use
Rhythmlink International Monopolar-Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The Rhythmlink International Monopolar-Stimulating-Instrument is sterile and for single use only

Source page: https://510kreport.com/device/K112435
Methodology: https://510kreport.com/methodology