510(k) · Cleared
ClearedAdherent Visual Stimulator Goggles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anschel Technology, Inc. · GWE Stimulator, Photic, Evoked Response
Cleared on Jun 6, 2012 as substantially equivalent to K831231 (Cadwell Laboratories, Inc., 1983) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jun 6, 2012
- Review
- 166 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010092 (2001). 3 ancestors in all, the oldest K831231 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010092 Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed)Excel Tech., Ltd. · 2001
- 1 generation backK011794 Xltek Led Goggles, Model Led-01Excel Tech., Ltd. · 2001
- This deviceK113785 Adherent Visual Stimulator GogglesAnschel Technology, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK200705 Nurochek SystemCryptych Pty, Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200705Nurochek SystemCryptych Pty, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010092 | Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed) | Excel Tech., Ltd. | 2001 | — |
| −1 | K011794 | Xltek Led Goggles, Model Led-01 | Excel Tech., Ltd. | 2001 | — |
| 0 (this device) | K113785 | Adherent Visual Stimulator Goggles | Anschel Technology, Inc. | 2012 | — |
| +1 | K200705 | Nurochek System | Cryptych Pty, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K831231 | Led GogglesSummary page 2…Visual Stimulator Goggles Stimulator Goggles K Number K113785 K831231 K011794 Same Intended Use! Yes Yes* Yes Indications for U… | 1983 |
| * | K011794 | Xltek Led Goggles, Model Led-01Summary page 2…Visual Stimulator Goggles Stimulator Goggles K Number K113785 K831231 K011794 Same Intended Use! Yes Yes* Yes Indications for Use Utilizes embedded… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200705 | Nurochek System | 2020 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200705 (Cryptych Pty, Ltd., 2020) has gone furthest, with 0 descendants 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. 2012, 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 SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation.
The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113785: Adherent Visual Stimulator Goggles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113785
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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