510(k) · Cleared
ClearedAlcon Multi-Pirpose Disinfecting Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · LPN Accessories, Soft Lens Products
Cleared on May 10, 2011 as substantially equivalent to K974723 (Bausch & Lomb, Inc., 1998) and 3 other predicates after a 222-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 10, 2011
- Review
- 222 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K021635 (2002). 6 ancestors in all, the oldest K974723 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK021635 Karats Multipurpose SolutionCiba Vision Corporation · 2002
- 2 generations backK033608 Aquify Multi-Purpose SolutionCiba Vision Corporation · 2004
- 1 generation backK083757 BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009 · Recalled
- This deviceK102860 Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021635 | Karats Multipurpose Solution | Ciba Vision Corporation | 2002 | — |
| −2 | K033608 | Aquify Multi-Purpose Solution | Ciba Vision Corporation | 2004 | — |
| −1 | K083757 | BPZ02 Multipurpose Solution | Bausch & Lomb, Inc. | 2009 | 2 |
| 0 (this device) | K102860 | Alcon Multi-Pirpose Disinfecting Solution | Alcon Research, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K974723 | Renu Multiplus Multi-Purpose SolutionSummary page 2…r Contact Lens Care Products. Alcon MPDS is substantially equivalent in terms of its actions and intended use to Bausch & freshTM multi-purpose solution (K974723), Bausch & LombTM1 BioTrueTM LombTM renu®& multi-purpose solution (K083757), Alcon OPTI-FREE®D Replenish® Multi-Purpose Disinf… | 1998 |
| * | K083757 | BPZ02 Multipurpose SolutionSummary page 2…rms of its actions and intended use to Bausch & freshTM multi-purpose solution (K974723), Bausch & LombTM1 BioTrueTM LombTM renu®& multi-purpose solution (K083757), Alcon OPTI-FREE®D Replenish® Multi-Purpose Disinfecting Solution (K050729) and Alcon Multi-Purpose Solution (K07 1236). A summ… | 2009 |
| * | K050729 | Alcon Multi-Purpose Disinfecting SolutionSummary page 2…rpose solution (K974723), Bausch & LombTM1 BioTrueTM LombTM renu®& multi-purpose solution (K083757), Alcon OPTI-FREE®D Replenish® Multi-Purpose Disinfecting Solution (K050729) and Alcon Multi-Purpose Solution (K07 1236). A summary of the test results is provided below: Safety and Effectiveness: Cle… | 2005 |
| * | K071236 | Alcon Multi-Purpose SolutionSummary page 2…BioTrueTM LombTM renu®& multi-purpose solution (K083757), Alcon OPTI-FREE®D Replenish® Multi-Purpose Disinfecting Solution (K050729) and Alcon Multi-Purpose Solution (K07 1236). A summary of the test results is provided below: Safety and Effectiveness: Cleaning: The cleaning efficacy of Alcon MPDS w… | 2007 |
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K974723.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102860: Alcon Multi-Pirpose Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102860
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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