510(k) · Cleared
ClearedSaccadometer Plus, Saccadometer Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ober Consulting Sp. Z.O.O. · HLL Monitor, Eye Movement
Cleared on Aug 11, 2016 as substantially equivalent to K902954 (Permobil AB, 1990) after a 316-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Aug 11, 2016
- Review
- 316 days
- Class
- Class II
- Product code
- HLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902954 (1990). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K222484RetitrackC. Light Technologies, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902954 | OBER2 Monitor, Eye Movement (Ophthalmic) | Permobil AB | 1990 | — |
| 0 (this device) | K152890 | Saccadometer Plus, Saccadometer Advanced | Ober Consulting Sp. Z.O.O. | 2016 | — |
| +1 | K222484 | Retitrack | C. Light Technologies, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 HLL? 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 HLL device
- #1 K222484 Retitrackscore 5.6 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K902954 | OBER2 Monitor, Eye Movement (Ophthalmic)Summary page 4…Common or usual name: Saccadometer Classification name: EYE MOVEMENT MONITOR (21 CFR 886.1510) Classification code: HLL III. PREDICATE DEVICE Permobil Meditech, Ober2, K902954 VI. DEVICE DESCRIPTION The Saccadometer system measures eye movements in horizontal axis with temporal 1kHz and spatial resolu… | 1990 |
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 |
|---|---|---|---|
| K222484 | Retitrack | 2023 | 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?
How does its category compare?
All HLL devicesHLL Monitor, Eye Movement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HLL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HLL
Too few HLL 510(k)s in any year since 2007 to give a median.
Recalls per year · HLL
No recall names HLL since 2007.
Adverse event reports per year · HLL
No MAUDE report names HLL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.
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/K152890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152890: Saccadometer Plus, Saccadometer Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152890
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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