Product code HQZ: 510(k) clearances and predicates
Product code HQZ covers SPECTACLE FRAME. FDA lists 198 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
198 clearances on file under product code HQZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest HQZ clearances in the FDA index, with applicant and decision date:
- K952597, VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW, applicant Point of View Optical Outlet, Inc., decided 1995-09-12. FDA record
- K944313, SPECTACLE FRAME, applicant Sun Hing Optical Manufactory , Ltd., decided 1995-03-28. FDA record
- K945392, SPECTACLE FRAME, applicant Seo Han Corp., Ltd., decided 1994-12-15. FDA record
- K945176, SPECTACLE FRAME OR EYEGLASS FRAMES, applicant Optipia Trading Co., decided 1994-12-15. FDA record
- K945770, OPTICAL FRAMES, applicant Ramada Optics, Inc., decided 1994-12-15. FDA record
- K945350, FRAME, SPECTACLES, applicant Taiwan Eva Industrial Co., Inc., decided 1994-12-13. FDA record
- K945342, MAG-1 SPECTACLE FRAME, applicant Criss Optical Mfg. Co., Inc., decided 1994-11-28. FDA record
- K945323, SPECTACLE FRAME, applicant M.Y. Vision Corp., decided 1994-11-22. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW, SPECTACLE FRAME OR EYEGLASS FRAMES. Watch new HQZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HQZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HQZ clearances include SPECTACLE FRAME.
How many 510(k) clearances use product code HQZ?
198 at the time this page was generated, from openFDA records.
How do I find a predicate device under HQZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HQZ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.