510(k) · Cleared
ClearedSauflon Multipurpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauflon Pharmaceuticals, Ltd. · LPN Accessories, Soft Lens Products
Cleared on May 15, 2013 as substantially equivalent to K050250 (Ciba Vision Corporation, 2005) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 15, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021635 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021635 | Karats Multipurpose Solution | Ciba Vision Corporation | 2002 | — |
| −1 | K033608 | Aquify Multi-Purpose Solution | Ciba Vision Corporation | 2004 | — |
| 0 (this device) | K130734 | Sauflon Multipurpose Solution | Sauflon Pharmaceuticals, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050250 | Aquify Multipurpose SolutionSummary page 1…substantial equivalent to the currently Equivalence: marketed Aquify Multipurpose Disinfecting Solution (K050250/K033608), 5. Device Description: Sauflon Multipurpose Solution is a sterile, isotonic sol… | 2005 |
| * | K033608 | Aquify Multi-Purpose SolutionSummary page 1…tial equivalent to the currently Equivalence: marketed Aquify Multipurpose Disinfecting Solution (K050250/K033608), 5. Device Description: Sauflon Multipurpose Solution is a sterile, isotonic solution th… | 2004 |
| † | K974485 | Sauflon All-in-One Light Contact Lens Solution | 1998 |
| † | K030278 | Sauflon Multipurpose Solution - NO Rub | 2003 |
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 11 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130734: Sauflon Multipurpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130734
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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