# K150005: Checkpoint, Checkpoint Head & Neck

- Pathway: 510(k) (Special)
- Applicant: Ndi Medical, LLC
- Decided: Feb 19, 2015 after 48 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: 3 generations back to K905045 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092292: Checkpoint, Ndi Medical, LLC (2009) Summary page 4.

## Most influential descendants
- K253536: Evala Nerve Stimulator (EPNR002) (2026), 0 descendants of its own

## Indications for use
The Checkpoint® Head & Neck 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/K150005
Methodology: https://510kreport.com/methodology