De Novo · Granted
GrantedPediatric Vision Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rebiscan, Inc. · PMW Strabismus Detection Device
Granted on Jun 8, 2016 as a new device type through De Novo after a 908-day review.
- Decided
- Jun 8, 2016
- Review
- 908 days
- Class
- Class II
- Product code
- PMW
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 PMW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All PMW devicesPMW Strabismus Detection Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PMW
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PMW
Too few PMW 510(k)s in any year since 2007 to give a median.
Recalls per year · PMW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMW
9in 2024
MAUDE reports naming product code PMW, 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 | — | 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 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pediatric Vision Scanner is intended for the automated detection of misalignment of the visual axes using polarized light. It is indicated for the screening of amblyopia and microstrabismus associated with amblyopia in children age 2 to 8 undergoing evaluation in a professional eye care setting and who are responsive to taking direction and who can pay attention for at least 5 seconds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130051 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130051: Pediatric Vision Scanner.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130051
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026