510(k) · Cleared
ClearedBenz-G 4X Hioxifilcon D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benz Research and Development Corp. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 6, 2007 as substantially equivalent to K051430 (Hydrogel Vision Corporation, 2005) after a 315-day review. Its family tree reaches back 2 generations to 1999. 7 later devices descend from it.
- Decided
- Aug 6, 2007
- Review
- 315 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992692 (1999). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
- 1 generation backK051430 Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and…Hydrogel Vision Corporation · 2005
- This deviceK062854 Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007
- Descendant · cites it directly · 3 of its ownK082393 Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA · 2008
- Descendant · 2 generations on · 2 of its ownK100456 Cvue Advanced DefinitiveUnilens Corp., USA · 2010
- Descendant · cites it directly · 1 of its ownK150590 CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily…Contamac, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK153305 EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily…Eyeyon Medical · 2016
- Descendant · 3 generations on · 0 of its ownK121652 Cvue Advanced Hydra VueUnilens Corp., USA · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082393Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA · 2008 · cites it directly3descendants
- K100456Cvue Advanced DefinitiveUnilens Corp., USA · 2010 · 2 generations on2descendants
- K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49…Contamac, Ltd. · 2015 · cites it directly1descendant
- K153305EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL…Eyeyon Medical · 2016 · 2 generations on0descendants
- K121652Cvue Advanced Hydra VueUnilens Corp., USA · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | Benz Research and Development Corp. | 1999 | — |
| −1 | K051430 | Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric) | Hydrogel Vision Corporation | 2005 | — |
| 0 (this device) | K062854 | Benz-G 4X Hioxifilcon D | Benz Research and Development Corp. | 2007 | — |
| +1 | K082393 | Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens | Unilens Corp., USA | 2008 | — |
| +2 | K100456 | Cvue Advanced Definitive | Unilens Corp., USA | 2010 | — |
| +1 | K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear… | Contamac, Ltd. | 2015 | — |
| +2 | K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear… | Eyeyon Medical | 2016 | — |
| +3 | K121652 | Cvue Advanced Hydra Vue | Unilens Corp., USA | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K051430 | Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)Summary page 2…hioxifilcon D) lathed soft contact lens is substantially equivalent to the Extreme H2 0® 54% (hioxifilcon D) molded soft contact lens already cleared under 5 10(k) K051430. In addition, Benz-G 4X (hioxifilcon D) lathed lens is manufactured at Benz Research & Development according to the same m… | 2005 |
| † | K952620 | Optical Blanks: BENZ55G Clear and Visibility Tinted | 1995 |
| † | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses… | 1997 |
What descends from it? (7)
3 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082393 (Unilens Corp., USA, 2008) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K051430.
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. 2007, this device’s year, is highlighted.
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 Benz G 4X (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 prescribe 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/K062854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062854: Benz-G 4X Hioxifilcon D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062854
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