510(k) · Cleared
ClearedRose K Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rose K International, Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on Feb 7, 1995 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.
- Decided
- Feb 7, 1995
- Review
- 63 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK945955 Rose K LensRose K International, Ltd. · 1995
- Descendant · cites it directly · 30 of its ownK990264 Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily…Metro Optics of Austin, Inc. · 1999
- Descendant · 2 generations on · 28 of its ownK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
- Descendant · 3 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- Descendant · 4 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- Descendant · 5 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K990264Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact LensMetro Optics of Austin, Inc. · 1999 · cites it directly30descendants
- K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · 2 generations on28descendants
- K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 3 generations on20descendants
- K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 4 generations on19descendants
- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945955 | Rose K Lens | Rose K International, Ltd. | 1995 | — |
| +1 | K990264 | Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear… | Metro Optics of Austin, Inc. | 1999 | — |
| +2 | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | Contamac, Ltd. | 2004 | 2 |
| +3 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| +4 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| +5 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990264 | Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact Lens | 1999 | 30 |
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, K990264 (Metro Optics of Austin, Inc., 1999) has gone furthest, with 30 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/K945955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945955: Rose K Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945955
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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