510(k) · Cleared
ClearedW-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted)
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 Jun 29, 1999 as substantially equivalent to K954524 (Westcon Contact Lens Co., Inc., 1996) after a 14-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it.
- Decided
- Jun 29, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954524 (1996). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954524 W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc. · 1996
- This deviceK992010 W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and…Westcon Contact Lens Co., Inc. · 1999
- Descendant · cites it directly · 5 of its ownK031774 Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK043540 Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
- Descendant · 4 generations on · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
- Descendant · 5 generations on · 0 of its ownK242059 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact…X-Cel Specialty Contacts, A Walman Optical Company · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004 · cites it directly5descendants
- K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005 · 2 generations on4descendants
- K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 2007 · 3 generations on2descendants
- K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010 · 4 generations on1descendant
- K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954524 | W-55 (Methafilon a) Contact Lens | Westcon Contact Lens Co., Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses | Westcon Contact Lens Co., Inc. | 2005 | — |
| +3 | K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for… | X-Cel Contacts | 2007 | — |
| +4 | K100443 | Definitive, Flexlens - Silicone Hydrogel | X-Cel Contacts, Inc. | 2010 | — |
| +5 | K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens… | X-Cel Specialty Contacts, A Walman Optical Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K954524 | W-55 (Methafilon a) Contact LensSummary page 2…the lens centration and comfort. Substantially Equivalent To: Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K954524 Summary of Safety and Effectiveness W-55 (methafilcon A) lens blank with visibility tint were subjected to extraction studies a… | 1996 |
What descends from it? (7)
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?
- Its one ancestor has no recall.
- Of its descendants, K031774 (Westcon Contact Lens Co., Inc., 2004) has gone furthest, with 5 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?
The Horizon 55 Westint and Horizon 55 (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of visual acuity in non aphaklc persons with non-diseased eyes with myopia or hyperopia.
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/K992010 · printed Nov 3, 2026
Cite this page
510(k) Report. “K992010: W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K992010
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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