510(k) · Cleared
ClearedMenicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menicon Co, Ltd. · LPN Accessories, Soft Lens Products
Cleared on Mar 2, 2020 as substantially equivalent to K142284 (Alcon Laboratories, Inc., 2015) and 1 other predicate after a 234-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Mar 2, 2020
- Review
- 234 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003345 (2001). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003345 Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
- 2 generations backK013512 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2001
- 1 generation backK142284 Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · Recalled
- This deviceK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253795 MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003345 | Aosept Plus Cleaning and Disinfecting Solution | Ciba Vision Corporation | 2001 | — |
| −2 | 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 |
| 0 (this device) | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | 2020 | — |
| +1 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeSummary page 4…Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution 3. Predicate Device Menicon claims substantial equivalence to K142284 Clear Care Plus Cleaning & Disinfecting Solution and K030522 Clear Care Cleaning & Disinfecting Solution. 510(k) Menicon… | 2015 |
| * | K030522 | Aosept Clear Care Cleaning and Disinfecting SolutionSummary page 4…Cleaning & Disinfecting Solution 3. Predicate Device Menicon claims substantial equivalence to K142284 Clear Care Plus Cleaning & Disinfecting Solution and K030522 Clear Care Cleaning & Disinfecting Solution. 510(k) Menicon 3% Peroxide CONFIDENTIAL… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | 2026 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K253795 (Menicon Co, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142284.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191872: Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191872
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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