510(k) · Cleared
ClearedISEN-Goggles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isen Tech & Trading Company, Ltd. · GWN Nystagmograph
Cleared on Apr 26, 2016 as substantially equivalent to K972631 (Ics Medical Corp., 1997) after a 217-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 26, 2016
- Review
- 217 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972631 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972631 Ics Medical Vemr Video Eye Movement RecorderIcs Medical Corp. · 1997
- This deviceK152727 ISEN-GogglesIsen Tech & Trading Company, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972631 | Ics Medical Vemr Video Eye Movement Recorder | Ics Medical Corp. | 1997 | — |
| 0 (this device) | K152727 | ISEN-Goggles | Isen Tech & Trading Company, Ltd. | 2016 | — |
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 GWN? 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 GWN device
- #1 K260566 SMARTVERTIGO™ Vestibular Assessment Systemscore 12.1 · 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 |
|---|---|---|---|
| * | K972631 | Ics Medical Vemr Video Eye Movement RecorderSummary page 4…on Name: 882.1460 Nystagmograph; GWN Nystagmograph Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Applicant K972631 GWN ICS Medical VEMR Video ICS Medical Corp. Eye Movement Re… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWN
203in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWN
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWN
1in 2025
MAUDE reports naming product code GWN, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 3 | 88 | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 165 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 4 | 160 | 0 | 0 |
| 2018 | 3 | 87 | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 3 | 203 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152727: ISEN-Goggles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152727
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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