510(k) · Cleared
ClearedMenicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
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 Mar 9, 2010 as substantially equivalent to K002140 (Menicon Co, Ltd., 2000) and 1 other predicate after a 526-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Mar 9, 2010
- Review
- 526 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002140 (2000). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002140 Menicon Progent RemoverMenicon Co, Ltd. · 2000
- This deviceK082855 Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK122273 Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK130285 Progent Large Diameter Contact Lens Case for Rigid Gas Permeable LensThe Lagado Corp. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002140 | Menicon Progent Remover | Menicon Co, Ltd. | 2000 | — |
| 0 (this device) | K082855 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | 2010 | — |
| +1 | K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lens | Menicon Co, Ltd. | 2013 | — |
| +2 | K130285 | Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens | The Lagado Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 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 10.7 · 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? (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 |
|---|---|---|---|
| * | K002140 | Menicon Progent RemoverSummary page 1…Devices Menicon claims substantial equivalence to Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses previously cleared under K002140. Substantial equivalence is also claimed to the Boston® Cleaner cleared under P820069. The Boston Clea… | 2000 |
| * | P820069 | Boston Lens (R) Cleaner FDA lists this PMA only through its supplements; the earliest we hold is P820069/S001 (Mar 16, 1984). Summary page 1…id Gas Permeable Contact Lenses previously cleared under K002140. Substantial equivalence is also claimed to the Boston® Cleaner cleared under P820069. The Boston Cleaner product isan RGP lens cleaner which isa potential irritant if placed directly into the eye, but… |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lens | 2013 | 1 |
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 MRC devicesMRC Products, Contact Lens Care, Rigid Gas Permeable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082855: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082855
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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