510(k) · Cleared
Cleared59% Extreme H2O (Hioxifilcon a) Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrogel Vision Corporation · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 2, 2005 as substantially equivalent to K992692 (Benz Research and Development Corp., 1999) after a 359-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Feb 2, 2005
- Review
- 359 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992692 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
- This deviceK040303 59% Extreme H2O (Hioxifilcon a) Soft Contact LensHydrogel Vision Corporation · 2005
- Descendant · cites it directly · 3 of its ownK201268 Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact…Plexus Optix, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK222885 Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2023
- Descendant · 3 generations on · 1 of its ownK232649 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK251095 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025
- Descendant · cites it directly · 0 of its ownK200618 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K201268Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Plexus Optix, Inc. · 2020 · cites it directly3descendants
- K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation · 2023 · 2 generations on2descendants
- K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2024 · 3 generations on1descendant
- K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025 · 4 generations on0descendants
- K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | Benz Research and Development Corp. | 1999 | — |
| 0 (this device) | K040303 | 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens | Hydrogel Vision Corporation | 2005 | — |
| +1 | K201268 | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59%… | Plexus Optix, Inc. | 2020 | — |
| +2 | K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Pegavision Corporation | 2023 | — |
| +3 | K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2024 | — |
| +4 | K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2025 | — |
| +1 | K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | Visco Vision, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact LensSummary page 1…from the FDA to expand the Indications for Use for the 59% Extreme H20 soft contact lens. The lens was originally approved on October 18, 1999, under 510(k) K992692, for the indication of daily wear correction of visual acuity in aphakic and not-aphakic persons with non-diseased ey… | 1999 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
The 59% Extreme H 2 0 (hioxifilcon A) toric 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 lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.
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.
https://510kreport.com/device/K040303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040303: 59% Extreme H2O (Hioxifilcon a) 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/K040303
Report an extraction error
Are you the manufacturer?
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