510(k) · Cleared
ClearedOptim-Eyes 450
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taylor/Fox Enterprises, LLC · HQY Sunglasses (Non-Prescription Including Photosensitive)
Cleared on Jun 13, 1997 as substantially equivalent to K900382 (Blublocker Corp., 1990) after a 24-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 13, 1997
- Review
- 24 days
- Class
- Class I
- Product code
- HQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900382 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK900382 Blublocker SunglassesBlublocker Corp. · 1990
- This deviceK971875 Optim-Eyes 450Taylor/Fox Enterprises, LLC · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900382 | Blublocker Sunglasses | Blublocker Corp. | 1990 | — |
| 0 (this device) | K971875 | Optim-Eyes 450 | Taylor/Fox Enterprises, LLC | 1997 | — |
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 HQY? 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? (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 |
|---|---|---|---|
| * | K900382 | Blublocker SunglassesSummary page 1…t. Substantial Equivalence The Optim-Eyes 450 sunglasses are substantially equivalent to commercially available sunglass products, including the Blublocker sunglasses (K900382). Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ;/é DEPARTMENT OF HEALTH & HUMAN SERV… | 1990 |
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 HQY devicesHQY Sunglasses (Non-Prescription Including Photosensitive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQY
FDA has decided no HQY device since 2007.
Median 510(k) review, days · HQY
Too few HQY 510(k)s in any year since 2007 to give a median.
Recalls per year · HQY
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQY
2in 2024
MAUDE reports naming product code HQY, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100X UVA and UVB, and blue light up to 450 nanometers.
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/K971875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971875: Optim-Eyes 450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971875
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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