510(k) Report

510(k) · Cleared

Cleared

Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens

K983773510(k) TraditionalCleared Dec 22, 199857-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 Dec 22, 1998 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Dec 22, 1998
Review
57 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2008: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2011: 1 descendant cleared2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983773 Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact LensBenz Research and Development Corp. · 1998
  2. Descendant · cites it directly · 5 of its ownK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
  3. Descendant · 2 generations on · 3 of its ownK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
  4. Descendant · 3 generations on · 1 of its ownK102895 One Day Flat PackMenicon Co, Ltd. · 2011
  5. Descendant · 3 generations on · 0 of its ownK192129 ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic)…Clearlab SG Pte, Ltd. · 2019
  6. Descendant · 3 generations on · 0 of its ownK180819 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12011: 12017: 12018: 12019: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all
  • K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006 · cites it directly5descendants
  • K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008 · 2 generations on3descendants
  • K102895One Day Flat PackMenicon Co, Ltd. · 2011 · 3 generations on1descendant
  • K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan…Clearlab SG Pte, Ltd. · 2019 · 3 generations on0descendants
  • K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983773Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact LensBenz Research and Development Corp.1998—
+1K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd.2006—
+2K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd.2008—
+3K102895One Day Flat PackMenicon Co, Ltd.2011—
+3K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact…Clearlab SG Pte, Ltd.2019—
+3K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
201110
201710
201810
201910
FIG. 1 — Lineage of K983773, 1998–2019Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd.20065
K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC20060

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, K052290 (Clearlab Pte, Ltd., 2006) has gone furthest, with 5 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 BENZ-G 5X SPHERICAL (hioxifilcon A) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and astigmatism of up to 0.75 Diopters where the astigmatism does not interfere with visual acuity. The lens may be disinfected with either a chemical or a heat disinfection system.

Indications for use read by OCR from a scanned FDA 510(k) statement, 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
  • K992692Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
  • 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/K983773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983773: Benz G-5X (Hioxifilcon a) Soft Daily Wear 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/K983773

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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