510(k) Report

510(k) · Cleared

Cleared

Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut From Lens Blan

K963837510(k) TraditionalCleared Dec 20, 199687-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Westcon Contact Lens Co., Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 20, 1996 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.

Decided
Dec 20, 1996
Review
87 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2002: 1 descendant cleared2005: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963837 Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily…Westcon Contact Lens Co., Inc. · 1996
  2. Descendant · cites it directly · 5 of its ownK031774 Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
  3. Descendant · 2 generations on · 4 of its ownK043540 Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
  4. Descendant · 3 generations on · 2 of its ownK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
  5. Descendant · 4 generations on · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
  6. 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

2002: 12004: 12005: 12007: 12008: 12010: 12024: 1
2002high 1 (2002) · low 0 (2003)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963837Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear…Westcon Contact Lens Co., Inc.1996—
+1K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc.2004—
+2K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc.2005—
+3K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for…X-Cel Contacts2007—
+4K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.2010—
+5K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens…X-Cel Specialty Contacts, A Walman Optical Company2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
200710
200810
201010
202410
FIG. 1 — Lineage of K963837, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc.20045
K023530Horizon 38 (Clear) and Horizon 38 Westint (Tinted)Westcon Contact Lens Co., Inc.20020

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, K031774 (Westcon Contact Lens Co., Inc., 2004) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

More from Westcon Contact Lens Co., Inc.

13 FDA decisions under this applicant name. See the company

  • K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
  • K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
  • K023530Horizon 38 (Clear) and Horizon 38 Westint (Tinted)Westcon Contact Lens Co., Inc. · 2002
  • P990072W-55 (Methafilcon a) and Horizon 55 Soft Extended Wear Contact LensesWestcon Contact Lens Co., Inc. · 2000
  • K992010W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55…Westcon Contact Lens Co., Inc. · 1999

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K963837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963837: Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut From Lens Blan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963837

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026