510(k) Report

510(k) · Cleared

Cleared

Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens

K020389510(k) TraditionalCleared Jun 4, 2002119-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

Ocular Sciences · MVN Lens, Contact, (Disposable)

Cleared on Jun 4, 2002 as substantially equivalent to K003136 (Ocular Sciences Puerto Rico, Inc., 2001) after a 119-day review. Its family tree reaches back 1 generation to 2001. 22 later devices descend from it.

Decided
Jun 4, 2002
Review
119 days
Class
Class II
Product code
MVN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003136 (2001). 22 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2011: 4 descendants cleared2013: 2 descendants cleared2017: 1 descendant cleared2022: 2 descendants cleared2020: 3 descendants cleared2016: 1 descendant cleared2019: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 3 descendants clearedK003136 · Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft Contact Lens · Ocular Sciences Puerto Rico, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 2 descendants K003136 · Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft Contact Lens · Ocular Sciences Puerto Rico, Inc. · 20010
  1. Root · 1 generation backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
  2. This deviceK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
  3. Descendant · cites it directly · 10 of its ownK131378 Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · Recalled
  4. Descendant · cites it directly · 9 of its ownK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 7 of its ownK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
  6. Descendant · 2 generations on · 6 of its ownK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
  7. Descendant · 2 generations on · 4 of its ownK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2006: 12011: 42013: 22016: 12017: 12018: 22019: 12020: 32021: 12022: 22024: 12026: 3
2006high 4 (2011) · low 0 (2007)2026

Most influential descendants

Showing 5 of 22 · See all
  • K131378Sus (Stenfilcon a) Contact LensCooperVision, Inc. · 2013 · cites it directly10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003136Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft…Ocular Sciences Puerto Rico, Inc.2001—
0 (this device)K020389Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences2002—
+1K131378Sus (Stenfilcon a) Contact LensCooperVision, Inc.20135
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201140
201320
201610
201710
201820
201910
202030
202110
202220
202410
202630
FIG. 1 — Lineage of K020389, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MVN? 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 MVN device

  1. #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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
*K003136Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.2001—

Also cleared against K003136: 1 other device →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K131378Sus (Stenfilcon a) Contact LensCooperVision, Inc.201310
K061948Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc.20069
K113267BIOPMEDICS52,52 1DAY,52 Toric,52 1DAY ToricCooperVision, 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?

  • Its one ancestor has no recall.
  • Of its descendants, K131378 (CooperVision, Inc., 2013) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K003136.

How does its category compare?

All MVN devices

MVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MVN

2in 2020

2007: 12008: 22011: 12013: 12015: 22020: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVN

Too few MVN 510(k)s in any year since 2007 to give a median.

Recalls per year · MVN

2in 2013

2009: 12011: 12013: 22026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · MVN

22in 2025

2010: 32011: 92012: 252013: 352014: 202015: 102016: 182017: 232018: 322019: 342020: 322021: 242022: 182023: 242024: 252025: 22
2007high 35 (2013) · low 0 (2007)2025

MAUDE reports naming product code MVN, 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
20071—00
20082—00
20090—10
20100—03
20111—19
20120—025
20131—235
20140—020
20152—010
20160—018
20170—023
20180—032
20190—034
20202—032
20210—024
20220—018
20230—024
20240—025
20250—022
20261—1—

What is it indicated for?

Spherical: BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity. Toric: BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophi1ic)UV Blocking Contact lenses are indicated for the correction of…

Read the full statement (138 words)

Spherical:

BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.

Toric:

BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophi1ic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters.

The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for single use disposable wear.

The BIOMEDICSB 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Indications for use as stated in the FDA summary.

Also cleared against K003136

1 other device cites the same predicate.

  • K113267BIOPMEDICS52,52 1DAY,52 Toric,52 1DAY ToricCooperVision, Inc. · 2011

Recent decisions in MVN

The MVN category page

  • K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily…HOYA Lamphun, Ltd. · 2026
  • K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc. · 2020
  • K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP…Alcon Laboratories, Inc. · 2020
  • K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV…Yung Sheng Optical Co., Ltd. · 2015
  • K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd. · 2015

https://510kreport.com/device/K020389 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020389: Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020389

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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