510(k) · Cleared
ClearedView Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun Pockets, Point of View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Point of View Optical Outlet, Inc. · HQZ Frame, Spectacle
Cleared on Sep 12, 1995 after a 98-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Sep 12, 1995
- Review
- 98 days
- Class
- Class I
- Product code
- HQZ
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQZ? 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 HQZ devicesHQZ Frame, Spectacle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQZ
FDA has decided no HQZ device since 2007.
Median 510(k) review, days · HQZ
Too few HQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HQZ
No recall names HQZ since 2007.
Adverse event reports per year · HQZ
1in 2023
MAUDE reports naming product code HQZ, 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 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952597: View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun Pockets, Point of View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952597
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026