510(k) · Cleared
ClearedSolo-Care Aqua Antimicrobial Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · LRX Case, Contact Lens
Cleared on Sep 9, 2005 as substantially equivalent to K943183 (Ciba Vision Corporation, 1994) after a 430-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 9, 2005
- Review
- 430 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943183 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK943183 Ciba Vision (R) Contact Lens CaseCiba Vision Corporation · 1994
- This deviceK041820 Solo-Care Aqua Antimicrobial Lens CaseCiba Vision Corporation · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943183 | Ciba Vision (R) Contact Lens Case | Ciba Vision Corporation | 1994 | — |
| 0 (this device) | K041820 | Solo-Care Aqua Antimicrobial Lens Case | Ciba Vision Corporation | 2005 | — |
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? (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 |
|---|---|---|---|
| * | K943183 | Ciba Vision (R) Contact Lens CaseSummary page 1…e Classification Name: Soft (hydmophilic) contact lens care products Propdietary Name: ProGuard Lens Case 3.Predicate Devices Contact Lens Case (K943183) 4.Description of the Devices Data indicate that lens cases are a significant source of microbial contamination. The ProG… | 1994 |
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 LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The ProGuard™ Lens Case is indicated, for storage of soft (hydrophilic) contact lenses with AQuify® Multipurpose Solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041820 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041820: Solo-Care Aqua Antimicrobial Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041820
Report an extraction error
Are you the manufacturer?
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