510(k) · Cleared
ClearedOpti-Free Supraclens Daily Protein Remover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · LPN Accessories, Soft Lens Products
Cleared on Mar 4, 1998 as substantially equivalent to P820001/
- Decided
- Mar 4, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P820001/
- Root · 1 generation backP820001/
S018 Opti-Free (R) Supra-Clens Daily Protein RemoverAlcon Laboratories · 1995 - This deviceK974625 Opti-Free Supraclens Daily Protein RemoverAlcon Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK990480 Opti-Free Supraclens Daily Protein RemoverAlcon Laboratories · 1999
Most influential descendants
Showing 1 of 1 · See all- K990480Opti-Free Supraclens Daily Protein RemoverAlcon Laboratories · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P820001/ | Opti-Free (R) Supra-Clens Daily Protein Remover | Alcon Laboratories | 1995 | — |
| 0 (this device) | K974625 | Opti-Free Supraclens Daily Protein Remover | Alcon Laboratories | 1998 | — |
| +1 | K990480 | Opti-Free Supraclens Daily Protein Remover | Alcon Laboratories | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 LPN? 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 LPN device
- #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 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 |
|---|---|---|---|
| * | P820001/ | Opti-Free (R) Supra-Clens Daily Protein Remover A supplement to the PMA, as the summary prints it. | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990480 | Opti-Free Supraclens Daily Protein Remover | 1999 | 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?
- Its one ancestor has no recall.
- Of its descendants, K990480 (Alcon Laboratories, 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, 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 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and
extended wear soft (hydrophilic) contact lens to simultaneously enzymatically clean them while
they are being disinfected (soaked) in Alcon Multi-Purpose Disinfecting Solution ID 90746,
OPTI-FREE Rinsing, Disinfection and Storage Solution, OPTI-FREE EXPRESS Multi-Purpose
Solution or OPTI-ONE Multi-Purpose Solution. Use as recommended by your eye care
practitioner.
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/K974625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974625: Opti-Free Supraclens Daily Protein Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974625
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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