# K072736: Rhythmlink International Monopolar Stimulating Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Jan 22, 2008 after 117 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980148 (1998). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes, Medtronic Xomed, Inc. (2003) Summary page 1.

## Most influential descendants
- K100992: Neuralmas (2010), 6 descendants of its own
- K131304: Sentio MMG (2014), 3 descendants of its own
- K173526: SENTIO MMG Gen 2 (2018), 2 descendants of its own
- K243636: Neuralytix iD3 System (NTX-9001) (2025), 1 descendant of its own
- K173134: SENTIO MMG Pedicle Access Needles (2018), 1 descendant of its own

## Recalls of this device
- May 4, 2015 · Class II · Z-1960-2015: Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm

## 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/K072736
Methodology: https://510kreport.com/methodology