510(k) · Cleared
ClearedHybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contamac, Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on Sep 12, 2002 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Sep 12, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK021977 Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily…Contamac, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK032256 Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a…No 7 Contact Lens Laboratory, Ltd. · 2003
Most influential descendants
Showing 1 of 1 · See all- K032256Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas…No 7 Contact Lens Laboratory, Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021977 | Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily Wear | Contamac, Ltd. | 2002 | — |
| +1 | K032256 | Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid… | No 7 Contact Lens Laboratory, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032256 | Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas… | 2003 | 0 |
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, K032256 (No 7 Contact Lens Laboratory, Ltd., 2003) has gone furthest, with 0 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 | — |
What is it indicated for?
The Contamac Hybrid FS (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and low level corneal toricity up to 2.000) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.
The Contamac Hybrid FS Toric (hybufocon A) RGP Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism where a spherical lens does not neutralize any residual over-refraction) in aphakic or not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfection only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021977: Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021977
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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