510(k) · Cleared
ClearedDuqiao
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Duqiao Glasses (Group) Co., Ltd. · HQY Sunglasses (Non-Prescription Including Photosensitive)
Cleared on Jun 4, 1997 after a 37-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 4, 1997
- Review
- 37 days
- Class
- Class I
- Product code
- HQY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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 sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized “Impact Resistant Lenses” made from glass or plastic.
As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can’t provide refractive corrections.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971551: Duqiao.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971551
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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