# K944547: Dantec Keypoint

- Pathway: 510(k) (Traditional)
- Applicant: Mckenna & Cuneo
- Decided: Sep 19, 1995 after 369 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070109: Neurometrix Advance (2008), 15 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K130346: Synergy Focus Desktop Version; Synergy Focus Laptop Version (2013), 3 descendants of its own

## Recalls of this device
- Apr 9, 2013 · Class II · Z-1407-2013: Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.

Source page: https://510kreport.com/device/K944547
Methodology: https://510kreport.com/methodology