FDA product code HQY: Sunglasses (Non-Prescription Including Photosensitive)
HQY is the FDA product code for sunglasses (non-prescription including photosensitive). It is a Class I device, regulated under 21 CFR 886.5850 and reviewed by the Ophthalmic panel. FDA has cleared 646 510(k) submissions under HQY, from 545 different applicants. The average 510(k) review took 92 days (median 64). FDA has posted 1 recall for HQY devices.
Classification
| Field | Value |
|---|---|
| Device name | Sunglasses (Non-Prescription Including Photosensitive) |
| Device class | Class I |
| Regulation | 21 CFR 886.5850 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HQY clearance
Top HQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J & B Assoc. | 10 | 1990-05-03 |
| The Orvis Co., Inc. | 9 | 1995-03-02 |
| Blublocker Corp. | 7 | 1996-01-11 |
| Sunny Sunglasses | 6 | 1994-07-12 |
| Walmart Stores | 5 | 1995-10-25 |
540 more applicants have HQY clearances. See the full list in Caduvo.
Most recent HQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974860 | Wenzhou Ming Ming Optical Co. , Ltd. | NON-PRESCRIPTION SUNGLASSES | 1998-01-30 | 32 |
| K974852 | Chia Hui Spectacles Mfg. Corp. | NON-PRESCRIPTION SUNGLASSES | 1998-01-30 | 32 |
| K974861 | Wenzhou Hindar Optical Co., Ltd. | NON-PRESCRIPTION SUNGLASSES | 1998-01-27 | 29 |
| K974511 | Sun World Intl., Inc. | SUNGLASSES | 1998-01-12 | 42 |
| K974441 | Hip Shing Fat Co., Ltd. | SUNGLASSES | 1998-01-09 | 45 |
Recalls for HQY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-11-24.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J8499 — Prescription drug, oral, non chemotherapeutic, nos
Frequently asked questions
What is FDA product code HQY?
HQY is the FDA product code for sunglasses (non-prescription including photosensitive). It is a Class I device, regulated under 21 CFR 886.5850 and reviewed by the Ophthalmic panel.
What device class is HQY?
Class I, regulation 21 CFR 886.5850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQY?
Across 646 cleared submissions the average was 92 days from receipt to decision (median 64).
Which companies have the most HQY clearances?
J & B Assoc. (10); The Orvis Co., Inc. (9); Blublocker Corp. (7); Sunny Sunglasses (6); Walmart Stores (5).
Have HQY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code HQY
- Run a recall and safety report across every HQY manufacturer
- Watch product code HQY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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