510(k) · Cleared
ClearedRigid Gas Permeable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology · HQD Lens, Contact (Other Material) - Daily
Cleared on Oct 31, 2000 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.
- Decided
- Oct 31, 2000
- Review
- 120 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 3 citing it directly.
- This deviceK002025 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- Descendant · cites it directly · 28 of its ownK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 27 of its ownK011945 Rigid Gas Permeable Contact Lens SolutionPolymer Technology Corp. · 2001
- Descendant · 2 generations on · 26 of its ownK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- Descendant · 3 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · cites it directly28descendants
- K011945Rigid Gas Permeable Contact Lens SolutionPolymer Technology Corp. · 2001 · cites it directly27descendants
- K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · 2 generations on26descendants
- K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 2 generations on20descendants
- K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002025 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| +1 | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | Contamac, Ltd. | 2004 | 2 |
| +1 | K011945 | Rigid Gas Permeable Contact Lens Solution | Polymer Technology Corp. | 2001 | — |
| +2 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| +2 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| +3 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 363 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, K033594 (Contamac, Ltd., 2004) has gone furthest, with 28 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.
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/K002025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002025: Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002025
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026