510(k) · Cleared
ClearedComfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas Permeable (RGP) Daily Wear Contact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metro Optics, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Feb 12, 2003 as substantially equivalent to K990264 (Metro Optics of Austin, Inc., 1999) after a 57-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 12, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945955 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK945955 Rose K LensRose K International, Ltd. · 1995
- 1 generation backK990264 Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily…Metro Optics of Austin, Inc. · 1999
- This deviceK024164 Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a…Metro Optics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K024164 | Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a)… | Metro Optics, Inc. | 2003 | — |
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990264 | Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact LensSummary page 2…Device name: 1.) 'Metro Optics of Austin, Inc. ComfortKonem, Keratoconus, Daily Wear 15802 Vision W v e 5 1O(k) #: K990264 PIlugeMe, TX 78660 5 1O(k) 990264 Device Description: The ComfortK~ve" Keratoconus Aspheric Contact Lens is fib… | 1999 |
| † | K021977 | Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily Wear | 2002 |
| † | K000485 | HYDRO2, HS-75 | 2000 |
| † | K044223 | Accucon |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K990264.
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 | — |
What is it indicated for?
The ComfortKoneTM Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K024164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024164: Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas Permeable (RGP) Daily Wear Contact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024164
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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