510(k) · Cleared
ClearedOsprey Spherical and Toric Multifocal Soft Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Florida Optical Engineering, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Dec 26, 2001 after a 70-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Dec 26, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK013445 Osprey Spherical and Toric Multifocal Soft Contact LensesFlorida Optical Engineering, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK140025 Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic)…Pegavision Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK173086 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2014 · cites it directly2descendants
- K150385NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc. · 2015 · 2 generations on1descendant
- K173086NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013445 | Osprey Spherical and Toric Multifocal Soft Contact Lenses | Florida Optical Engineering, Inc. | 2001 | — |
| +1 | K140025 | Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2014 | — |
| +2 | K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | 2015 | — |
| +3 | K173086 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | — | UltraVue/P and UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lenses Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140025 | Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses | 2014 | 2 |
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, K140025 (Pegavision Corporation, 2014) has gone furthest, with 2 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?
The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity.
The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less.
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/K013445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013445: Osprey Spherical and Toric Multifocal Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026