510(k) Report

510(k) · Cleared

Cleared

Extreme H20 (Hioxifilicon a) Soft Contact Lens

K992692510(k) TraditionalCleared Oct 18, 199968-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

Benz Research and Development Corp. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Oct 18, 1999 after a 68-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.

Decided
Oct 18, 1999
Review
68 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

32 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2020: 2 descendants cleared2016: 3 descendants cleared2007: 1 descendant cleared2018: 2 descendants cleared2017: 1 descendant cleared2019: 2 descendants cleared2011: 2 descendants cleared2022: 2 descendants cleared2015: 1 descendant cleared2010: 2 descendants cleared2024: 3 descendants cleared2023: 3 descendants cleared2025: 2 descendants cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
  2. Descendant · cites it directly · 22 of its ownK051430 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 · 2 generations on · 7 of its ownK062854 Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007
  6. Descendant · cites it directly · 5 of its ownK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 12008: 22010: 22011: 22012: 12015: 12016: 32017: 12018: 22019: 22020: 22022: 22023: 32024: 32025: 2
2005high 3 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 32 · See all
  • K051430Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)Hydrogel Vision Corporation · 2005 · cites it directly22descendants
  • 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 · 2 generations on7descendants
  • K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992692Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp.1999—
+1K051430Extreme 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—
+2K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp.2007—
+1K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200710
200820
201020
201120
201210
201510
201630
201710
201820
201920
202020
202220
202330
202430
202520
FIG. 1 — Lineage of K992692, 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
*—Benz Research and Development Benz Lens “lathe cut” version
Named without a submission number
—

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K051430Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)Hydrogel Vision Corporation200522
K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58…INTEROJO, Inc.201612
K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd.20065
K04030359% Extreme H2O (Hioxifilcon a) Soft Contact LensHydrogel Vision Corporation20055
K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd.20083
K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc.20200

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, K051430 (Hydrogel Vision Corporation, 2005) has gone furthest, with 22 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?

The 59% extreme H₂O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint.

Eyecare 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 either a heat or chemical disinfection system.

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

More from Benz Research and Development Corp.

12 FDA decisions under this applicant name. See the company

  • K101122Benz-G 4X (Hioxifilcon D) Multifocal Lathed LensBenz Research and Development Corp. · 2010
  • K062854Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007
  • K003861Benz-MF (Visibility Hangling Tint) (Methafilcon a) Soft Daily Wear Contact Lens (Lathe-Cut)Benz Research and Development Corp. · 2001
  • K983773Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact LensBenz Research and Development Corp. · 1998
  • K980418Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses…Benz Research and Development Corp. · 1998

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/K992692 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992692: Extreme H20 (Hioxifilicon a) Soft 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/K992692

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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