# K051357: DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH

- Pathway: 510(k) (Traditional)
- Applicant: Digitimer, Ltd.
- Decided: Sep 20, 2005 after 119 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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 K020400 (2002). 1 ancestor in all.
40 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020400: Digitimer D185 Multipulse Cortical Stimulator, Meps, LLC (2002) Summary page 1.

## Most influential descendants
- K112718: Nuvasive NVM5 System (2012), 35 descendants of its own
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own

## Indications for use
The DS7A and DS7AH are stinmilators intended for use during neurological monitoring and assessment in a clinical environment. They are intended for use by trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.

Source page: https://510kreport.com/device/K051357
Methodology: https://510kreport.com/methodology