# K061365: Checkpoint with Accustim Technology

- Pathway: 510(k) (Traditional)
- Applicant: Ndi Medical, LLC
- Decided: Jul 12, 2006 after 57 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: 1 generation back to K905045 (1991). 2 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K905045: Nerve Locator/Stimulator, Aaron Medical Industries (1991) Summary page 1.
- K934426: Nerve Integrity Monitor-2 (Nim-2 XL), Xomed-Treace, Inc. (1994) Summary page 1.
- (no number) Medtronic Xomed Vari-Stim III: named in the summary without a submission number

## Most influential descendants
- K092292: Checkpoint (2009), 4 descendants of its own
- 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 CheckpointTM is a single-use 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.

Source page: https://510kreport.com/device/K061365
Methodology: https://510kreport.com/methodology