510(k) · Cleared
ClearedLifelines iEEG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kvikna Ehf · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Aug 21, 2015 as substantially equivalent to K964280 (Medelec, Ltd., 1997) after a 256-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Aug 21, 2015
- Review
- 256 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964280 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964280 DG NervusMedelec, Ltd. · 1997 · Recalled
- This deviceK143487 Lifelines iEEGKvikna Ehf · 2015
- Descendant · cites it directly · 1 of its ownK242306 SignalNED System (Model RE)Forest Devices, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK251726 SignalNED System (Model RE)Forest Devices, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964280 | DG Nervus | Medelec, Ltd. | 1997 | 1 |
| 0 (this device) | K143487 | Lifelines iEEG | Kvikna Ehf | 2015 | — |
| +1 | K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | 2024 | — |
| +2 | K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964280 | DG NervusSummary page 4…mpany Product 510(k) # Natus Medical, Inc DG Nervus K964280 DEVICE DESCRIPTION Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242306 | SignalNED System (Model RE) | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143487: Lifelines iEEG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143487
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026