510(k) Report

510(k) · Cleared

Cleared

Proclear (Omafilcon a) Daily Wear Contact Lens

K974408510(k) TraditionalCleared Apr 16, 1998143-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

Biocompatibles Eyewear, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Apr 16, 1998 after a 143-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.

Decided
Apr 16, 1998
Review
143 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2011: 3 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant clearedReference device: K952152 · Proclear Daily Wear Contact Lens · Biocompatibles, Ltd. · 1995Reference device: K970095 · Proclear Compatibles Daily Wear Contact Lens · Biocompatibles Eyewear, Inc. · 19971995200020052010201520202025
  1. This deviceK974408 Proclear (Omafilcon a) Daily Wear Contact LensBiocompatibles Eyewear, Inc. · 1998
  2. Descendant · cites it directly · 9 of its ownK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 7 of its ownK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
  4. Descendant · 2 generations on · 6 of its ownK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
  5. Descendant · 2 generations on · 4 of its ownK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017
  6. Descendant · 3 generations on · 1 of its ownK180985 Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd · 2018

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12011: 32013: 12017: 12018: 12020: 12022: 12026: 1
2006high 3 (2011) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · cites it directly9descendants
  • K110099Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…CooperVision, Inc. · 2011 · 2 generations on7descendants
  • K112302Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…CooperVision, Inc. · 2011 · 2 generations on6descendants
  • K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017 · 2 generations on4descendants
  • K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd · 2018 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974408Proclear (Omafilcon a) Daily Wear Contact LensBiocompatibles Eyewear, Inc.1998—
+1K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc.20061
+2K110099Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…CooperVision, Inc.2011—
+2K112302Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear…CooperVision, Inc.2011—
+2K162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd2017—
+3K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201130
201310
201710
201810
202010
202210
202610
FIG. 1 — Lineage of K974408, 1998–2026Source: 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), 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Proclear (omafilcon A) Contact Lens
Named without a submission number
—
†K952152Proclear Daily Wear Contact LensBiocompatibles, Ltd.1995—
†K970095Proclear Compatibles Daily Wear Contact LensBiocompatibles Eyewear, Inc.1997—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc.20069
K111966Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XCCooperVision, Inc.20110

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, K061948 (CooperVision, Inc., 2006) has gone furthest, with 9 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—

What is it indicated for?

(omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren’s only).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Biocompatibles Eyewear, Inc.

3 FDA decisions under this applicant name. See the company

  • K980218Methafilcon a Soft (Hydrophilic) Contact Lens for Daily WearBiocompatibles Eyewear, Inc. · 1998
  • K970095Proclear Compatibles Daily Wear Contact LensBiocompatibles Eyewear, Inc. · 1997

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/K974408 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974408: Proclear (Omafilcon a) Daily Wear Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974408

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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