510(k) · Cleared
ClearedKarats Multipurpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · LPN Accessories, Soft Lens Products
Cleared on Oct 28, 2002 after a 164-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 28, 2002
- Review
- 164 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK021635 Karats Multipurpose SolutionCiba Vision Corporation · 2002
- Descendant · cites it directly · 4 of its ownK033608 Aquify Multi-Purpose SolutionCiba Vision Corporation · 2004
- Descendant · 2 generations on · 2 of its ownK083757 BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 0 of its ownK210051 OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK130734 Sauflon Multipurpose SolutionSauflon Pharmaceuticals, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK102860 Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K033608Aquify Multi-Purpose SolutionCiba Vision Corporation · 2004 · cites it directly4descendants
- K083757BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009 · 2 generations on2descendants
- K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021 · 3 generations on0descendants
- K130734Sauflon Multipurpose SolutionSauflon Pharmaceuticals, Ltd. · 2013 · 2 generations on0descendants
- K102860Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021635 | Karats Multipurpose Solution | Ciba Vision Corporation | 2002 | — |
| +1 | K033608 | Aquify Multi-Purpose Solution | Ciba Vision Corporation | 2004 | — |
| +2 | K083757 | BPZ02 Multipurpose Solution | Bausch & Lomb, Inc. | 2009 | 2 |
| +3 | K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021 | — |
| +2 | K130734 | Sauflon Multipurpose Solution | Sauflon Pharmaceuticals, Ltd. | 2013 | — |
| +3 | K102860 | Alcon Multi-Pirpose Disinfecting Solution | Alcon Research, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | SOLOCare Plus Multipurpose Solution Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033608 | Aquify Multi-Purpose Solution | 2004 | 4 |
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, K033608 (Ciba Vision Corporation, 2004) has gone furthest, with 4 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?
Karats MPS is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021635: Karats Multipurpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021635
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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