510(k) · Cleared
ClearedAmpleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Art Optical Contact Lens, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Sep 20, 2017 after a 50-day review. The FDA summary names no predicate by number. 10 later devices descend from it.
- Decided
- Sep 20, 2017
- Review
- 50 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK172314 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A…Art Optical Contact Lens, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK212631 Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022
- Descendant · cites it directly · 6 of its ownK203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK223394 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2022
- Descendant · 2 generations on · 4 of its ownK233325 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2024
- Descendant · 2 generations on · 4 of its ownK213538 Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas…Acuity Polymers, Inc. · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022 · cites it directly7descendants
- K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · cites it directly6descendants
- K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC · 2022 · 2 generations on5descendants
- K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC · 2024 · 2 generations on4descendants
- K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) | Art Optical Contact Lens, Inc. | 2017 | — |
| +1 | K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2022 | — |
| +1 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021 | — |
| +2 | K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon… | Visionary Optics, LLC | 2022 | — |
| +2 | K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon… | Visionary Optics, LLC | 2024 | — |
| +2 | K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable… | Acuity Polymers, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
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 HQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K212631 (Contamac, Ltd., 2022) has gone furthest, with 7 descendants of its own.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, 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 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K172314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172314: Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172314
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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