# K965065: Teca.  Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Medelec, Ltd.
- Decided: Jun 20, 1997 after 184 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.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have 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
- K112052: Carefusion Nicolet Edx (2012), 30 descendants of its own
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent (2017), 12 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own

## Indications for use
The indications for use statements shown below are now to be included in the Millennium User Manual, see Introduction Section under the headings of System Overview and Cautions and Warnings respectively. The Millennium is a 2 or 5 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment. Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner.

Source page: https://510kreport.com/device/K965065
Methodology: https://510kreport.com/methodology