510(k) · Cleared
ClearedNatus Photic Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · GWE Stimulator, Photic, Evoked Response
Cleared on Jun 15, 2018 as substantially equivalent to K101691 (Lifelines, Ltd., 2010) after a 171-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jun 15, 2018
- Review
- 171 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003154 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
- 3 generations backK041198 NIC36 AmplifierEb Neuro S.P.A. · 2004
- 2 generations backK053606 BE Plus / Aura-LTM64 AmplifierEb Neuro S.P.A. · 2006
- 1 generation backK101691 Lifelines Photic StimulatorLifelines, Ltd. · 2010
- This deviceK173936 Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003154 | Mizar, Basis BE, Sandman Digital | Eb Neuro S.P.A. | 2001 | — |
| −3 | K041198 | NIC36 Amplifier | Eb Neuro S.P.A. | 2004 | — |
| −2 | K053606 | BE Plus / Aura-LTM64 Amplifier | Eb Neuro S.P.A. | 2006 | — |
| −1 | K101691 | Lifelines Photic Stimulator | Lifelines, Ltd. | 2010 | — |
| 0 (this device) | K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | — |
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 |
|---|---|---|---|
| * | K101691 | Lifelines Photic StimulatorSummary page 4…Predicate 510(k) Predicate Equivalent Devices: Number Manufacturer / Model XLTEK / Natus Photic K101691 Lifelines Ltd. / Lifelines Stimulator Photic Stimulator… | 2010 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K101691.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Natus 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/K173936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173936: Natus 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/K173936
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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