510(k) · Cleared
ClearedContact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maca Plastics, Inc. · LRX Case, Contact Lens
Cleared on Sep 10, 2014 as substantially equivalent to K120969 (Arlington Contact Lens Services,Inc., 2012) after a 195-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Sep 10, 2014
- Review
- 195 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920064 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 3 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- 2 generations backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- 1 generation backK120969 AC Lens Branded Contact Lens CaseArlington Contact Lens Services,Inc. · 2012
- This deviceK140488 Contact Lens CaseMaca Plastics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172925 Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017
Most influential descendants
Showing 1 of 1 · See all- K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −3 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| −2 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| −1 | K120969 | AC Lens Branded Contact Lens Case | Arlington Contact Lens Services,Inc. | 2012 | — |
| 0 (this device) | K140488 | Contact Lens Case | Maca Plastics, Inc. | 2014 | — |
| +1 | K172925 | Contact Lens Case, Model: A-1, B-1 | P L Overseas Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K120969 | AC Lens Branded Contact Lens CaseSummary page 4…quivalent Device Company Device Name K Number Arlington Contact Lens Service, Contact Lens Case K120969 Inc. DEVICE DESCRIPTION 807.92(a) (4) Our contact lens case will consist… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172925 | Contact Lens Case, Model: A-1, B-1 | 2017 | 0 |
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 22 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K172925 (P L Overseas Limited, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. Use for storage during chemical disinfections only. Do not use heat disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140488: Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140488
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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