# K143487: Lifelines iEEG

- Pathway: 510(k) (Traditional)
- Applicant: Kvikna Ehf
- Decided: Aug 21, 2015 after 256 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K964280 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964280: DG Nervus, Medelec, Ltd. (1997) Summary page 4.

## Most influential descendants
- K242306: SignalNED System (Model RE) (2024), 1 descendant of its own
- K251726: SignalNED System (Model RE) (2025), 0 descendants of its own

## Indications for use
The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient’s condition to the user.

Source page: https://510kreport.com/device/K143487
Methodology: https://510kreport.com/methodology