510(k) · Cleared
ClearedProgent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Lagado Corp. · LRX Case, Contact Lens
Cleared on Apr 3, 2013 as substantially equivalent to K991206 (Bonasse Ent. Co., Ltd., 2000) and 1 other predicate after a 57-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 3, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002140 (2000). 5 ancestors in all, the oldest K991206 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002140 Menicon Progent RemoverMenicon Co, Ltd. · 2000
- 2 generations backK082855 Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2010
- 1 generation backK122273 Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2013
- This deviceK130285 Progent Large Diameter Contact Lens Case for Rigid Gas Permeable LensThe Lagado Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002140 | Menicon Progent Remover | Menicon Co, Ltd. | 2000 | — |
| −2 | 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 | — |
| 0 (this device) | K130285 | Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens | The Lagado Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 LRX? 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 LRX device
- #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.3 · 5 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 |
|---|---|---|---|
| * | K991206 | Bonasse Contact Lens CaseSummary page 1…ontact Lens Case For Rigid Gas Permeable Contact Lenses 3. Predicate Devices Lagado Corporation claims substantial equivalence to K991206 Bonasse Non-Vented Barrel Style Contact Lens Case and the Progent SP Vial cleared in 510(k) K 122273. 4. Description o… | 2000 |
| * | K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensSummary page 1…Lagado Corporation claims substantial equivalence to K991206 Bonasse Non-Vented Barrel Style Contact Lens Case and the Progent SP Vial cleared in 510(k) K 122273. 4. Description of Device The Menicon Progent Large Diameter Contact Lens Case is a non-vented barrel style contact len… | 2013 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K991206.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRX
49in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRX
No recall names LRX since 2007.
Adverse event reports per year · LRX
1in 2021
MAUDE reports naming product code LRX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 103 | 0 | 1 |
| 2013 | 4 | 72 | 0 | 0 |
| 2014 | 3 | 249 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 5 | 49 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses.
The Menicon Progent Large Diameter Contact Lens Case provides an alternative lens case to hold large diameter lenses (11I mm to 23 mm) during the Menicon Progent Protein Remover treatment. The case is not intended for disinfection (chemical, heat or peroxide). The case is not intended for lens storage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130285: Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130285
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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