510(k) · Cleared
ClearedBiomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocular Sciences Puerto Rico, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jan 21, 1999 as substantially equivalent to K942214 (Martin S. Knopf Assoc., Inc., 1994) and 2 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1994. 15 later devices descend from it.
- Decided
- Jan 21, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942214 (1994). 3 ancestors in all, the oldest P890023 (1989). 15 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 1 generation backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- This deviceK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
- Descendant · cites it directly · 11 of its ownK020193 Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft…Cl Mcintosh · 2002
- Descendant · cites it directly · 10 of its ownK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001
- Descendant · 2 generations on · 9 of its ownK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · Recalled
- Descendant · cites it directly · 4 of its ownK013377 Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 2001
- Descendant · 3 generations on · 3 of its ownK181232 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensCl Mcintosh · 2002 · cites it directly11descendants
- K012425Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001 · cites it directly10descendants
- K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · 2 generations on9descendants
- K013377Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 2001 · cites it directly4descendants
- K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV…Largan Medical Co., Ltd. · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −1 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| 0 (this device) | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| +1 | K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic)… | Cl Mcintosh | 2002 | — |
| +1 | K012425 | Biomedics UV Multifocal | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| +2 | K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2010 | 1 |
| +1 | K013377 | Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| +3 | K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan… | Largan Medical Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K942214 | H55 Hydrophilic Contact LensSummary page 1…NT TO: The BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens with In- Monomer Tint is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, P890023/S4,and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocul… | 1994 |
| * | P890023 | H55 Hydrophilic Contact LensSummary page 1…he BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear Contact Lens with In- Monomer Tint is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, P890023/S4,and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Scienc… | 1989 |
| * | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensSummary page 1…D) UV Blocking Daily Wear Contact Lens with In- Monomer Tint is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, P890023/S4,and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Sciences, Inc. The BIOMEDICSR® 55… | 1997 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens | 2002 | 11 |
| K012425 | Biomedics UV Multifocal | 2001 | 10 |
| K013377 | Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens | 2001 | 4 |
| K992264 | Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact Lens | 1999 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K020193 (Cl Mcintosh, 2002) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K942214.
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 BIOMEDICS® 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent…
Read the full statement (118 words)
The BIOMEDICS® 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
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/K984046 · printed Nov 3, 2026
Cite this page
510(k) Report. “K984046: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K984046
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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