510(k) · Cleared
ClearedAquify Multi-Purpose 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 Feb 2, 2004 as substantially equivalent to K021635 (Ciba Vision Corporation, 2002) after a 77-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Feb 2, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021635 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021635 Karats Multipurpose SolutionCiba Vision Corporation · 2002
- This deviceK033608 Aquify Multi-Purpose SolutionCiba Vision Corporation · 2004
- Descendant · cites it directly · 2 of its ownK083757 BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK210051 OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021
- Descendant · cites it directly · 0 of its ownK130734 Sauflon Multipurpose SolutionSauflon Pharmaceuticals, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK102860 Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K083757BPZ02 Multipurpose SolutionBausch & Lomb, Inc. · 2009 · cites it directly2descendants
- K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021 · 2 generations on0descendants
- K130734Sauflon Multipurpose SolutionSauflon Pharmaceuticals, Ltd. · 2013 · cites it directly0descendants
- K102860Alcon Multi-Pirpose Disinfecting SolutionAlcon Research, Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021635 | Karats Multipurpose Solution | Ciba Vision Corporation | 2002 | — |
| 0 (this device) | K033608 | Aquify Multi-Purpose Solution | Ciba Vision Corporation | 2004 | — |
| +1 | K083757 | BPZ02 Multipurpose Solution | Bausch & Lomb, Inc. | 2009 | 2 |
| +2 | K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021 | — |
| +1 | K130734 | Sauflon Multipurpose Solution | Sauflon Pharmaceuticals, Ltd. | 2013 | — |
| +2 | K102860 | Alcon Multi-Pirpose Disinfecting Solution | Alcon Research, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K021635 | Karats Multipurpose SolutionSummary page 1…n Proprietary Name: AQUIFY Multi-purpose Solution 3. Predicate Device(s) AQuify Multi-purpose Solution (KARATS Multi-purpose Solution) - K021635 4. Description of the Device AQuify Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, trometh… | 2002 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K083757 (Bausch & Lomb, Inc., 2009) has gone furthest, with 2 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?
AQuify Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, stoding for soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multi-purpose Solution is also indicated for daily protein removal of lenses replaced in 30 days or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033608: Aquify Multi-Purpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033608
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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