510(k) · Cleared
ClearedMulti-Purpose Disinfecting Solution ID 90746
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 Jan 14, 1999 as substantially equivalent to K973332 (Alcon Laboratories, 1997) after a 22-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 14, 1999
- Review
- 22 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973332 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK973332 Alcon Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1997
- This deviceK984575 Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973332 | Alcon Multi-Purpose Disinfecting Solution ID 90746 | Alcon Laboratories | 1997 | — |
| 0 (this device) | K984575 | Multi-Purpose Disinfecting Solution ID 90746 | Alcon Laboratories | 1999 | — |
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 |
|---|---|---|---|
| * | K973332 | Alcon Multi-Purpose Disinfecting Solution ID 90746Summary page 1…90746 (minor specification modification) is substantially equivalent, in terms of its actions and indications for use, to Multi-Purpose Disinfecting Solution ID 90746 (K973332). Multi-Purpose Disinfecting Solution ID 90746 (minor specification modification) meets the guidelines set forth… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K973332.
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?
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-ZYME® Enzymatic Cleaner.
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/K984575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984575: Multi-Purpose Disinfecting Solution ID 90746.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984575
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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