510(k) · Cleared
ClearedAosept Clear Care Cleaning and Disinfecting 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 Dec 20, 2001 as substantially equivalent to K003345 (Ciba Vision Corporation, 2001) after a 59-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 59 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003345 (2001). 7 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK003345 Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
- This deviceK013512 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
- Descendant · cites it directly · 3 of its ownK142284 Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK162597 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK173538 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK253795 MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · cites it directly3descendants
- K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2016 · cites it directly2descendants
- K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020 · 2 generations on1descendant
- K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2017 · cites it directly1descendant
- K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003345 | Aosept Plus Cleaning and Disinfecting Solution | Ciba Vision Corporation | 2001 | — |
| 0 (this device) | K013512 | Aosept Clear Care Cleaning and Disinfecting Solution | Ciba Vision Corporation | 2001 | — |
| +1 | K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde | Alcon Laboratories, Inc. | 2015 | 1 |
| +1 | K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2016 | — |
| +2 | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | 2020 | — |
| +1 | K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2017 | — |
| +3 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K003345 | Aosept Plus Cleaning and Disinfecting Solution Our OCR of the scanned summary read “K003345.” beside “510(k)”; FDA’s K003345 is the only number that fits it and carries the summary’s name for the device. Summary page 1…f Safety and Substantial Equivalence Cleaning Studies Previous studies have demonstrated the cleaning capacity of AOSEPT Clear Care Cleaning and Disinfecting Solution (K003345) with soft contact lenses. The study previously submitted and reviewed demonstrated that AOSept Clear Care was substantially equi… | 2001 |
| * | — | OptiFree Express Named without a submission number | |
| * | — | Bausch & Lomb ReNu Multi-Purpose Solution Named without a submission number |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde | 2015 | 3 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | 2016 | 2 |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | 2017 | 1 |
| K191795 | AOCup Lens Case with AODisc | 2019 | 0 |
| K111877 | EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and Disinfecting… | 2012 | 0 |
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?
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?
AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
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/K013512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013512: Aosept Clear Care Cleaning and 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/K013512
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026