# K020400: Digitimer D185 Multipulse Cortical Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Meps, LLC
- Decided: Aug 23, 2002 after 198 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
No predicates in its family tree.
468 later devices descend from it; 5 cite it directly.
1 of 469 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032741: Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation (2003), 462 descendants of its own
- K050798: Eclipse Neurological Workstation (2005), 460 descendants of its own
- K061113: Orthomon (2006), 450 descendants of its own
- K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon (2006), 426 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own

## Indications for use
The Digitimer D185 is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Source page: https://510kreport.com/device/K020400
Methodology: https://510kreport.com/methodology