510(k) · Cleared
ClearedAlcon Multi-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 Dec 2, 1997 after an 89-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Dec 2, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
2 later devices descend from it, 2 citing it directly.
- This deviceK973332 Alcon Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1997
- Descendant · cites it directly · 0 of its ownK021143 Opti-Free Express Multi-Purpose Disinfecting SolutionAlcon Universal, Ltd. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK984575 Multi-Purpose Disinfecting Solution ID 90746Alcon Laboratories · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973332 | Alcon Multi-Purpose Disinfecting Solution ID 90746 | Alcon Laboratories | 1997 | — |
| +1 | K021143 | Opti-Free Express Multi-Purpose Disinfecting Solution | Alcon Universal, Ltd. | 2002 | 1 |
| +1 | K984575 | Multi-Purpose Disinfecting Solution ID 90746 | Alcon Laboratories | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P830034/ | Alcon OPTI-FREE Multi-Purpose Solution Number could not be read Summary page 1…of its actions and indications to Alcon OPTI-FREE® Multi-Purpose Solution and Alcon OPTI-ONE® Multi-Purpose Solution. These two products were cleared for marketing under P830034/S27 and P830034/S26 respectively. Alcon Multi-Purpose Disinfecting Solution ID 90746 meets the guidelines set forth in FDA’s May 1,… | |
| Kept off the family tree | P830034/ | Alcon OPTI-ONE Multi-Purpose Solution Number could not be read Summary page 1…nd indications to Alcon OPTI-FREE® Multi-Purpose Solution and Alcon OPTI-ONE® Multi-Purpose Solution. These two products were cleared for marketing under P830034/S27 and P830034/S26 respectively. Alcon Multi-Purpose Disinfecting Solution ID 90746 meets the guidelines set forth in FDA’s May 1, 1997 Guidance fo… |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K021143 (Alcon Universal, Ltd., 2002) 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?
For the daily cleaning, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. For use in chemical (not heat) disinfection.
Alcon Multi-Purpose Disinfecting Solution ID 90746 can also be used as a diluent for
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/K973332 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973332: Alcon 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/K973332
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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