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 Mar 25, 2013 as substantially equivalent to K090019 (Natus Medical, Inc., 2010) and 2 other predicates after a 117-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 25, 2013
- Review
- 117 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K964280 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964280 DG NervusMedelec, Ltd. · 1997 · Recalled
- This deviceK123665 Lifelines IeegKvikna Ehf · 2013
View 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) | K123665 | Lifelines Ieeg | Kvikna Ehf | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K090019 | Natus Neuroworks, Model 104196Summary page 1…807.92(a)(3) Legally Marketed Equivalent Device K Number Product Cornpany K090019 INatus Neuroworks, Model 104196 Natus Medical, Inc. K964280 DG Nervus… | 2010 |
| * | K964280 | DG NervusSummary page 1…Product Cornpany K090019 INatus Neuroworks, Model 104196 Natus Medical, Inc. K964280 DG Nervus Natus Medical, Inc. K02 1185 Nervus Monitor… | 1997 |
| * | K021185 | Nervus MonitorSummary page 1…INatus Neuroworks, Model 104196 Natus Medical, Inc. K964280 DG Nervus Natus Medical, Inc. K02 1185 Nervus Monitor Taugagreining hf DEVICE DESCRIPTION… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 3 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090019.
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. 2013, 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 a software system that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
* The Lifelines iEEG software allows display, archive, review and analysis of physiological signals.
* Lifelines iEEG also includes the display of a quantitative EEG plot, 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/K123665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123665: Lifelines Ieeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123665
Report an extraction error
Are you the manufacturer?
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