510(k) · Cleared
ClearedBenz 38 Clear & with Blue Visibility Tint
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 23, 1996 after a 156-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Aug 23, 1996
- Review
- 156 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK961103 Benz 38 Clear & with Blue Visibility TintBenz Research and Development Corp. · 1996
- Descendant · cites it directly · 4 of its ownK980554 Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear…Alden Optical Labs., Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK983278 Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear…Alden Optical Labs., Inc. · 1998
- Descendant · cites it directly · 2 of its ownK023987 Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear…Contamac, Ltd. · 2003
- Descendant · 3 generations on · 2 of its ownK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK132714 Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses…Vision Science Co., Ltd. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K980554Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens…Alden Optical Labs., Inc. · 1998 · cites it directly4descendants
- K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Alden Optical Labs., Inc. · 1998 · 2 generations on3descendants
- K023987Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted…Contamac, Ltd. · 2003 · cites it directly2descendants
- K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999 · 3 generations on2descendants
- K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961103 | Benz 38 Clear & with Blue Visibility Tint | Benz Research and Development Corp. | 1996 | — |
| +1 | K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| +2 | K983278 | Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| +1 | K023987 | Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and… | Contamac, Ltd. | 2003 | — |
| +3 | K992950 | Custom Prosthetic (Hefilcon a) Soft Lens | Prosthetic Soft Lens Corp. | 1999 | — |
| +2 | K132714 | Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear… | Vision Science Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens… | 1998 | 4 |
| K023987 | Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted… | 2003 | 2 |
| K973967 | AL-47 (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted… | 1997 | 0 |
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, K980554 (Alden Optical Labs., Inc., 1998) has gone furthest, with 4 descendants of its own.
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?
BENZ 38 (polvmacon) Spherical soft (hvdrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eves. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50° Diopters of astigmatism where it does not interfere with visual acuity. BENZ 38 (poiymacon) Toric soft…
Read the full statement (131 words)
BENZ 38 (polvmacon) Spherical soft (hvdrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eves. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50° Diopters of astigmatism where it does not interfere with visual acuity.
BENZ 38 (poiymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in ncn-aphakic patients with with non-diseased eves. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961103: Benz 38 Clear & with Blue Visibility Tint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961103
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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