510(k) · Cleared
ClearedLifelines Photic Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifelines, Ltd. · GWE Stimulator, Photic, Evoked Response
Cleared on Aug 10, 2010 as substantially equivalent to K053606 (Eb Neuro S.P.A., 2006) after a 55-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 10, 2010
- Review
- 55 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003154 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- 2 generations backK041198 NIC36 AmplifierEb Neuro S.P.A. · 2004
- 1 generation backK053606 BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006
- This deviceK101691 Lifelines Photic StimulatorLifelines, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK251366 EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit…Nihon Kohden Corporation · 2025
- Descendant · cites it directly · 0 of its ownK211974 LED PHOTIC SystemMicromed S.P.A. · 2021
- Descendant · cites it directly · 0 of its ownK173936 Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018
Most influential descendants
Showing 3 of 3 · See all- K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…Nihon Kohden Corporation · 2025 · cites it directly0descendants
- K211974LED PHOTIC SystemMicromed S.P.A. · 2021 · cites it directly0descendants
- K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −2 | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| −1 | K053606 | BE Plus / Aura-LTM64 Amplifier | Eb Neuro S.P.A. | 2006 | — |
| 0 (this device) | K101691 | Lifelines Photic Stimulator | Lifelines, Ltd. | 2010 | — |
| +1 | K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A)… | Nihon Kohden Corporation | 2025 | — |
| +1 | K211974 | LED PHOTIC System | Micromed S.P.A. | 2021 | — |
| +1 | K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 GWE? 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 GWE device
- #1 K211643 Vision Monitor - MonpackONEscore 5.0 · 2 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 |
|---|---|---|---|
| * | K053606 | BE Plus / Aura-LTM64 AmplifierSummary page 1…evice Class: Class II PREDICATE DEVICE Legally Marketed Equivalent Device EB Neuro, S.P.A. BE Plus / AURA-LTM64 Amplifier K053606 DEVICE DESCRIPTION The Photic Stimulator is a device for generating short-duration flashes of white light by means of a solid-s… | 2006 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K251366 (Nihon Kohden Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053606.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GWE
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GWE
Too few GWE 510(k)s in any year since 2007 to give a median.
Recalls per year · GWE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWE
1in 2025
MAUDE reports naming product code GWE, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101691: Lifelines Photic Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101691
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