510(k) · Cleared
ClearedMenicon Progent Remover
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 Oct 10, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 10, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK002140 Menicon Progent RemoverMenicon Co, Ltd. · 2000
- Descendant · cites it directly · 2 of its ownK082855 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
- Descendant · cites it directly · 0 of its ownK020930 Menicon Progent Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2002
Most influential descendants
Showing 4 of 4 · See all- K082855Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2010 · cites it directly2descendants
- K122273Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2013 · cites it directly1descendant
- K130285Progent Large Diameter Contact Lens Case for Rigid Gas Permeable LensThe Lagado Corp. · 2013 · 2 generations on0descendants
- K020930Menicon Progent Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002140 | Menicon Progent Remover | Menicon Co, Ltd. | 2000 | — |
| +1 | 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 | — |
| +1 | K020930 | Menicon Progent Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K082855 (Menicon Co, Ltd., 2010) has gone furthest, with 2 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K002140 · printed Nov 3, 2026
Cite this page
510(k) Report. “K002140: Menicon Progent Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002140
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026