510(k) · Cleared
ClearedMenicon Unique PH Multi-Purpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menicon Co, Ltd. · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on Jul 3, 2013 as substantially equivalent to K000148 (Alcon Laboratories, 2000) after a 100-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jul 3, 2013
- Review
- 100 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000148 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000148 RGP Multi-Purpose Solution ID 100136Alcon Laboratories · 2000
- This deviceK130805 Menicon Unique PH Multi-Purpose SolutionMenicon Co, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000148 | RGP Multi-Purpose Solution ID 100136 | Alcon Laboratories | 2000 | — |
| 0 (this device) | K130805 | Menicon Unique PH Multi-Purpose Solution | Menicon Co, Ltd. | 2013 | — |
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 MRC? 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 MRC device
- #1 K251876 cleadew GP hydra onescore 10.8 · 3 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 |
|---|---|---|---|
| * | K000148 | RGP Multi-Purpose Solution ID 100136Summary page 1…Devices Menicon claims substantial equivalence to Alcon RGP Multi-Purpose Solution ID 100136 for Rigid Gas Permeable Contact Lenses previously cleared under K000 148 on April 11, 2000. 4. Description. of Device Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous soluti… | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MRC devicesMRC Products, Contact Lens Care, Rigid Gas Permeable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MRC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRC
51in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRC
72in 2025
MAUDE reports naming product code MRC, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 51 | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 72 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permecable contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130805: Menicon Unique PH Multi-Purpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130805
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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