510(k) Report

510(k) · Cleared

Cleared

Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)

K051430510(k) TraditionalCleared Jul 18, 200547-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

Hydrogel Vision Corporation · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jul 18, 2005 as substantially equivalent to K992692 (Benz Research and Development Corp., 1999) after a 47-day review. Its family tree reaches back 1 generation to 1999. 22 later devices descend from it.

Decided
Jul 18, 2005
Review
47 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K992692 (1999). 22 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2016: 3 descendants cleared2018: 1 descendant cleared2015: 1 descendant cleared2010: 2 descendants cleared2008: 1 descendant cleared2022: 2 descendants cleared2019: 1 descendant cleared2011: 1 descendant cleared2024: 3 descendants cleared2023: 3 descendants cleared2025: 2 descendants cleared2012: 1 descendant clearedReference device: K952620 · Optical Blanks: BENZ55G Clear and Visibility Tinted · Benz Research and Development Corp. · 1995Reference device: K964528 · (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint · Benz Research and Development Corp. · 1997K992692 · Extreme H20 (Hioxifilicon a) Soft Contact Lens · Benz Research and Development Corp. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K992692 · Extreme H20 (Hioxifilicon a) Soft Contact Lens · Benz Research and Development Corp. · 19990+5
  1. Root · 1 generation backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
  2. This deviceK051430 Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and…Hydrogel Vision Corporation · 2005
  3. Descendant · cites it directly · 12 of its ownK153766 Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily…INTEROJO, Inc. · 2016
  4. Descendant · 2 generations on · 7 of its ownK213119 Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2022
  5. Descendant · cites it directly · 7 of its ownK062854 Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007
  6. Descendant · 2 generations on · 3 of its ownK082393 Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA · 2008
  7. Descendant · 3 generations on · 2 of its ownK222885 Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2023

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 22011: 12012: 12015: 12016: 32018: 12019: 12022: 22023: 32024: 32025: 2
2007high 3 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all
  • K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58…INTEROJO, Inc. · 2016 · cites it directly12descendants
  • K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2022 · 2 generations on7descendants
  • K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007 · cites it directly7descendants
  • K082393Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA · 2008 · 2 generations on3descendants
  • K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation · 2023 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992692Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp.1999—
0 (this device)K051430Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)Hydrogel Vision Corporation2005—
+1K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear…INTEROJO, Inc.2016—
+2K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.2022—
+1K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp.2007—
+2K082393Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA2008—
+3K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201020
201110
201210
201510
201630
201810
201910
202220
202330
202430
202520
FIG. 1 — Lineage of K051430, 1999–2025Source: 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
*K992692Extreme H20 (Hioxifilicon a) Soft Contact Lens
Summary page 1
…me H 2 0® 54% £hioxifilcon D) soft contact lens is substantially equivalent to our 59% Extreme H 2 0 (hioxifilcon A) soft contact lens already cleared under 5 10(k) K992692. Device Description: Extreme H 2 0® 54% (hioxifilcon D) soft contact lenses are hemispherical shells…
Benz Research and Development Corp.1999—
†K952620Optical Blanks: BENZ55G Clear and Visibility TintedBenz Research and Development Corp.1995—
†K964528(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Benz Research and Development Corp.1997—

Also cleared against K992692: 5 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58…INTEROJO, Inc.201612
K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp.20077
K181050Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20180
K161124EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily WearVision Science Co., Ltd.20160

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, K153766 (INTEROJO, Inc., 2016) has gone furthest, with 12 descendants of its own.
  • 5 other devices also cite its predicate K992692.

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?

The Extreme H 2 0® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Indications for use as stated in the FDA summary.

Also cleared against K992692

5 other devices cite the same predicate.

  • K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc. · 2020
  • K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft…INTEROJO, Inc. · 2016
  • K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
  • K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
  • K04030359% Extreme H2O (Hioxifilcon a) Soft Contact LensHydrogel Vision Corporation · 2005

More from Hydrogel Vision Corporation

2 FDA decisions under this applicant name. See the company

  • K04030359% Extreme H2O (Hioxifilcon a) Soft Contact LensHydrogel Vision Corporation · 2005

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/K051430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051430: Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051430

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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