510(k) · Cleared
ClearedHorizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westcon Contact Lens Co., Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 1, 2005 as substantially equivalent to K031774 (Westcon Contact Lens Co., Inc., 2004) after a 41-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 1, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954524 (1996). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954524 W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc. · 1996
- 2 generations backK992010 W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and…Westcon Contact Lens Co., Inc. · 1999
- 1 generation backK031774 Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
- This deviceK043540 Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
- Descendant · cites it directly · 2 of its ownK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
- Descendant · 2 generations on · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK242059 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact…X-Cel Specialty Contacts, A Walman Optical Company · 2024
- Descendant · cites it directly · 0 of its ownK080686 Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co. · 2008
Most influential descendants
Showing 4 of 4 · See all- K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 2007 · cites it directly2descendants
- K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010 · 2 generations on1descendant
- K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024 · 3 generations on0descendants
- K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954524 | W-55 (Methafilon a) Contact Lens | Westcon Contact Lens Co., Inc. | 1996 | — |
| −2 | K992010 | W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55… | Westcon Contact Lens Co., Inc. | 1999 | — |
| −1 | K031774 | Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses | Westcon Contact Lens Co., Inc. | 2004 | — |
| 0 (this device) | K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses | Westcon Contact Lens Co., Inc. | 2005 | — |
| +1 | K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for… | X-Cel Contacts | 2007 | — |
| +2 | K100443 | Definitive, Flexlens - Silicone Hydrogel | X-Cel Contacts, Inc. | 2010 | — |
| +3 | K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens… | X-Cel Specialty Contacts, A Walman Optical Company | 2024 | — |
| +1 | K080686 | Westcon Horizon 49% (Hioxifilcon B) | Westcon Contact Lens Co. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2024 | 1 | 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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | K031774 | Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesSummary page 2…eactive Red 180. 5.0 Substantially Equivalent To: Westcon will be claiming equivalency to our own that is currently FDA approved in 510(k) K031774. 6.0 Summary of Safety and Effectiveness The Horizon lenses were subjected to leachability studies and showed n… | 2004 |
| † | K954524 | W-55 (Methafilon a) Contact Lens | 1996 |
What descends from it? (4)
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?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070308 (X-Cel Contacts, 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
Horizon 59 Oasis (hioxifilcon A) Spherical, Horizon 59 Oasis (hioxifilcon A) Toric, Horizon 59 Oasis (hioxifilcon A) Bi-con, Horizon 59 Oasis (hioxifilcon A) Bi-con Torie, Horizon 59 Oasis (hioxifilcon A) Progressive, Horizon 59 Oasis (hioxifilcon A) Progressive Torie are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes.
The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color.
The lenses may be disinfected using chemical systems only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043540: Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043540
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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