# K132138: Rhythmlink Disposable Concentric Stimulating Probe

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Apr 11, 2014 after 274 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- 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
Longest line of descent: 6 generations back to K923056 (1992). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,, Cadwell Lab, Inc. (2011) Summary page 1.

## Most influential descendants
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K223765: ATEC Lateral Navigation Instruments (2023), 0 descendants of its own

## Indications for use
The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery. The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device.

Source page: https://510kreport.com/device/K132138
Methodology: https://510kreport.com/methodology