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 Nov 16, 2017 as substantially equivalent to K923437 (Polymer Technology Corp., 1992) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 16, 2017
- Review
- 48 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K974466 (1998). 3 ancestors in all, the oldest K923437 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK974466 Boston Advance CleanerPolymer Technology Corp. · 1998
- This deviceK173136 Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974466 | Boston Advance Cleaner | Polymer Technology Corp. | 1998 | — |
| 0 (this device) | K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P860029 | Boston Cleaner Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…on number: 21 CFR 886.5918 Product code: MRC 3. Predicate Devices The predicate devices are the RGP contact lens cleaners, Boston Cleaner (P860029) and Boston Advance Cleaner (K923437 and K974466). These products are sold over the counter without prescription. 4. Descr… | |
| * | K923437 | Boston Cleaner IISummary page 4…roduct code: MRC 3. Predicate Devices The predicate devices are the RGP contact lens cleaners, Boston Cleaner (P860029) and Boston Advance Cleaner (K923437 and K974466). These products are sold over the counter without prescription. 4. Description of Device Menicon Progent Pro… | 1992 |
| * | K974466 | Boston Advance CleanerSummary page 4…MRC 3. Predicate Devices The predicate devices are the RGP contact lens cleaners, Boston Cleaner (P860029) and Boston Advance Cleaner (K923437 and K974466). These products are sold over the counter without prescription. 4. Description of Device Menicon Progent Protein Remover… | 1998 |
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?
- None of the 2 ancestors has a 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. 2017, 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/K173136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173136: 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/K173136
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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