# K092292: Checkpoint

- Pathway: 510(k) (Traditional)
- Applicant: Ndi Medical, LLC
- Decided: Oct 28, 2009 after 91 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
Longest line of descent: 2 generations back to K905045 (1991). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061365: Checkpoint with Accustim Technology, Ndi Medical, LLC (2006) Summary page 1.

## Most influential descendants
- K150005: Checkpoint, Checkpoint Head & Neck (2015), 1 descendant of its own
- K253536: Evala Nerve Stimulator (EPNR002) (2026), 0 descendants of its own
- K212355: Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large (2021), 0 descendants of its own
- K200886: StimSite (2020), 0 descendants of its own

## Indications for use
The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability. The Checkpoint is available for prescription use only.

Source page: https://510kreport.com/device/K092292
Methodology: https://510kreport.com/methodology