510(k) · Cleared
ClearedWestcon Horizon 49% (Hioxifilcon B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westcon Contact Lens Co. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 22, 2008 as substantially equivalent to K043540 (Westcon Contact Lens Co., Inc., 2005) and 1 other predicate after a 42-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Apr 22, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954524 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK954524 W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc. · 1996
- 3 generations backK992010 W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and…Westcon Contact Lens Co., Inc. · 1999
- 2 generations backK031774 Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
- 1 generation backK043540 Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
- This deviceK080686 Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954524 | W-55 (Methafilon a) Contact Lens | Westcon Contact Lens Co., Inc. | 1996 | — |
| −3 | K992010 | W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55… | Westcon Contact Lens Co., Inc. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 1997 | 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 |
|---|---|---|---|
| * | K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesSummary page 1…Predicate Device(s) TM Westcon Horizon 49 (hioxifilcon B) Horizonrm59 (hioxifilcon A) (K043540) Benz-G 3X (hioxifilcon B) Spherical and… | 2005 |
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 1…Lenses for Daily Wear in Clear and with a Blue Visibility Tint (K964528) IV. Device Description & Technological Characteristics The Westcon Horizonrm 49 (hioxifilcon B) soft contact lenses… | 1997 |
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 12 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K043540.
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. 2008, this device’s year, is highlighted.
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 TM 49 (hioxifilcon B) Spherical, Horizon TM 49 (hioxifilcon B) Toric, HorizonTM 49 (hioxifilcon B) Bi-con, HorizonTM 49 (hioxifilcon B) Bi-con Toric, Horizon TM 49 (hioxifilcon B) Progressive, HorizonTM 49 (hioxifilcon B) Progressive Toric for daily wear are indicated for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.
The lenses may be disinfected using chemical systems only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080686 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080686: Westcon Horizon 49% (Hioxifilcon B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080686
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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