510(k) · Cleared
ClearedHorizon (Methafilcon a) Daily Wear Sphere and Toric 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 20, 2004 as substantially equivalent to K992010 (Westcon Contact Lens Co., Inc., 1999) and 1 other predicate after a 256-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 256 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954524 (1996). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954524 W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc. · 1996
- 1 generation backK992010 W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and…Westcon Contact Lens Co., Inc. · 1999
- This deviceK031774 Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
- Descendant · cites it directly · 4 of its ownK043540 Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
- Descendant · 3 generations on · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK242059 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact…X-Cel Specialty Contacts, A Walman Optical Company · 2024
- Descendant · 2 generations on · 0 of its ownK080686 Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co. · 2008
Most influential descendants
Showing 5 of 5 · See all- K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005 · cites it directly4descendants
- K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 2007 · 2 generations on2descendants
- K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010 · 3 generations on1descendant
- K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024 · 4 generations on0descendants
- K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954524 | W-55 (Methafilon a) Contact Lens | Westcon Contact Lens Co., Inc. | 1996 | — |
| −1 | K992010 | W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55… | Westcon Contact Lens Co., Inc. | 1999 | — |
| 0 (this device) | K031774 | Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses | Westcon Contact Lens Co., Inc. | 2004 | — |
| +1 | K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses | Westcon Contact Lens Co., Inc. | 2005 | — |
| +2 | K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for… | X-Cel Contacts | 2007 | — |
| +3 | K100443 | Definitive, Flexlens - Silicone Hydrogel | X-Cel Contacts, Inc. | 2010 | — |
| +4 | K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens… | X-Cel Specialty Contacts, A Walman Optical Company | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K992010 | W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear)…Summary page 2…80. 5.0 Substantially Equivalent To: Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K992010 and 510(k) K963837. 6.0 Summary of Safety and Effectiveness The Horizon lenses were subjected to leachability stud… | 1999 |
| * | K963837 | Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens…Summary page 2…ally Equivalent To: Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K992010 and 510(k) K963837. 6.0 Summary of Safety and Effectiveness The Horizon lenses were subjected to leachability studies and showed no… | 1996 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses | 2005 | 4 |
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 1 company; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K043540 (Westcon Contact Lens Co., Inc., 2005) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K992010.
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 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive…
Read the full statement (195 words)
Horizon 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric 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.
The Horizon 38 (polymacon), Horizon 38 (polymacon) Westint, Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism) 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 color-enhanced lenses can be chemically disinfected only. The clear lenses may be disinfected using a heat or chemical disinfecting system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031774: Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031774
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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