510(k) · Cleared
ClearedXltek Led Goggles, Model Led-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Tech., Ltd. · GWE Stimulator, Photic, Evoked Response
Cleared on Oct 1, 2001 as substantially equivalent to K010092 (Excel Tech., Ltd., 2001) after a 115-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Oct 1, 2001
- Review
- 115 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010092 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK010092 Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed)Excel Tech., Ltd. · 2001
- This deviceK011794 Xltek Led Goggles, Model Led-01Excel Tech., Ltd. · 2001
- Descendant · cites it directly · 1 of its ownK113785 Adherent Visual Stimulator GogglesAnschel Technology, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK200705 Nurochek SystemCryptych Pty, Ltd. · 2020
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 | K010092 | Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed) | Excel Tech., Ltd. | 2001 | — |
| 0 (this device) | K011794 | Xltek Led Goggles, Model Led-01 | Excel Tech., Ltd. | 2001 | — |
| +1 | K113785 | Adherent Visual Stimulator Goggles | Anschel Technology, Inc. | 2012 | — |
| +2 | K200705 | Nurochek System | Cryptych Pty, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K010092 | Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed)Summary page 1…05) 829-5304 [email protected] LED Visual Stimulator Goggles 21 CFR § 882.1890, Stimulator Photic Evoked Response, 84 GWE, Class II XLTEK Real Patient EP 8 [510(k) # K010092] LED Visual Stimulator Goggles are goggles that are used to stimulate the eyes to record an electrical response from the brain.… | 2001 |
| * | — | Grass-Telefactor LED Goggles Named without a submission number |
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 |
|---|---|---|---|
| K113785 | Adherent Visual Stimulator Goggles | 2012 | 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?
- Its one ancestor has no recall.
- Of its descendants, K113785 (Anschel Technology, Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 LED Visual Stimulator Goggles are intended to
flash visible light into a patient’s eyes. The LED Visual
Stimulator Goggles are designed to be used in hospital
and clinical settings by trained medical personnel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011794: Xltek Led Goggles, Model Led-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026