Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HQY — Predicate Candidate Screening
646 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
207 days90th percentile
646clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 | 32 | 0 |
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | 1998-01-30 | 32 | 0 |
| K974861 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | 1998-01-27 | 29 | 0 |
| K974511 | SUNGLASSES | Sun World Intl., Inc. | 1998-01-12 | 42 | 0 |
| K974441 | SUNGLASSES | Hip Shing Fat Co., Ltd. | 1998-01-09 | 45 | 0 |
| K974414 | MULTI | Morning Calm Corp. | 1997-12-08 | 14 | 0 |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 | 82 | 0 |
| K974179 | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | 1997-12-01 | 25 | 0 |
| K974045 | VENNETO | Amsure Sports, Inc. | 1997-11-20 | 27 | 0 |
| K973934 | SUNGLASSES | Elegance Optical Manufactory, Ltd. | 1997-11-18 | 34 | 0 |
| K973526 | SUNGLASSES | Pyramid Handbags, Inc. | 1997-10-16 | 28 | 0 |
| K973490 | SUNGLASSES | Tong Yang Optical Co. | 1997-09-30 | 15 | 0 |
| K973407 | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | 1997-09-30 | 21 | 0 |
| K973016 | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLAS | Optimaxx Intl. | 1997-09-17 | 35 | 0 |
| K972850 | SUNGLASSES | Indoptica, S.A. | 1997-09-17 | 47 | 0 |
| K972717 | RUFF WORK EYEGEAR | Ruff House, Inc. | 1997-08-25 | 35 | 0 |
| K972590 | NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES | Lbi U.S.A. | 1997-07-31 | 20 | 0 |
| K972490 | D'ARC EYE CARE SUNGLASSES | M & R Dist. | 1997-07-25 | 23 | 0 |
| K972416 | MOMO DESIGN OR MOMO | Momo U.S.A., Inc. | 1997-07-21 | 24 | 0 |
| K972362 | FOVS, BRILLARTE, ETC... | Sunglass City, Inc. | 1997-07-14 | 19 | 0 |
| K971385 | SUNGLASSES | Kosway Industries Co., Ltd. | 1997-07-14 | 91 | 0 |
| K971462 | SUNGLASSES | D.G. Prove Co. | 1997-07-01 | 71 | 0 |
| K971384 | (BRAND NAME) | Long IN Time Ent. Co., Ltd. | 1997-07-01 | 78 | 0 |
| K972246 | SPECTACLE FRAMES (NON-PRESCRIPTION) | Alimar Trading, Inc. | 1997-06-26 | 10 | 0 |
| K972014 | SUNGLASSES (NON-PRESCRIPTION) | Tamfort, Ltd. | 1997-06-24 | 25 | 0 |
| K972194 | RIVIERA SUNGLASS4ES | Riviera Optical Co., Ltd. | 1997-06-24 | 14 | 0 |
| K971644 | CEBE | Suunto USA | 1997-06-24 | 50 | 0 |
| K971875 | OPTIM-EYES 450 | Taylor/Fox Enterprises, LLC | 1997-06-13 | 24 | 0 |
| K971707 | SUNGLASSES (NON-PRESCRIPTION) | Niko Sunglasses Corp. | 1997-06-13 | 38 | 0 |
| K971087 | SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) | W.J. Byrnes & Co. of Los Angeles, Inc. | 1997-06-13 | 80 | 0 |
| K970816 | GLARE WARE | Ergovision, Inc. | 1997-06-05 | 91 | 0 |
| K971551 | DUQIAO | Duqiao Glasses (Group) Co. , Ltd. | 1997-06-04 | 37 | 0 |
| K971495 | PATHFINDER SUNGLASSES | Coil | 1997-05-29 | 35 | 0 |
| K971412 | SUNGLASSES | Team Chien Industrial Co., Ltd. | 1997-05-13 | 27 | 0 |
| K970699 | AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES | Yeong Jiuh Corp. | 1997-05-13 | 77 | 0 |
| K971327 | UNIKA | Eyewear Partners Co. | 1997-05-09 | 29 | 0 |
| K971249 | GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN | Andrew G. Halpern | 1997-05-06 | 33 | 0 |
| K971326 | ARROW COMPANY | Excel Eyewear Corp. | 1997-05-06 | 26 | 0 |
| K970759 | SOLAR SPECS | Morris Rosenbloom & Co., Inc. | 1997-05-06 | 64 | 0 |
| K971104 | CLASSIC MATCH | Delagar Division Belcam, Inc. | 1997-05-06 | 41 | 0 |
| K970454 | LAXIMA INTERNATIONAL LIMITED SUNGLASSES | Laxima Intl., Ltd. | 1997-05-06 | 90 | 0 |
| K970895 | CUSTOM OPTICAL SUNGLASS FRAMES | Custom Optical Frames, Inc. | 1997-05-06 | 56 | 0 |
| K970944 | BARAKKA, INFERNO, STERLING, AND/OR ONE | Sentinal Importing Corp. | 1997-05-06 | 54 | 0 |
| K970476 | HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) | Hwa Mao Optical Co., Ltd. | 1997-05-06 | 88 | 0 |
| K970315 | EVEREST SUNGLASSES | Ycc International Corp. | 1997-05-06 | 99 | 0 |
| K970744 | STYLE EYES OPTICS | Anti-Ray, Inc. | 1997-03-31 | 31 | 0 |
| K970538 | VICTORY EYEWEAR CO | Victory Eyewear Co., Ltd. | 1997-03-25 | 41 | 0 |
| K965125 | DAKOTA SMITH, NICOLE MILLER SUNGLASSES | California Design Studio, Inc. | 1997-03-19 | 86 | 0 |
| K965170 | ROCCOBAROCCO & PRO-DYNAMIX | Michelangelo, Inc. | 1997-03-11 | 77 | 0 |
| K970101 | JAMES ALEX SUNGLASSES | D&K Stores, Inc. | 1997-03-04 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda