510(k) · Cleared
ClearedLANDR Contact LENS Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fourth Axis, LLC · LRX Case, Contact Lens
Cleared on Feb 10, 2026 as substantially equivalent to K240095 (Shanghai Care US Medical Product Co., Ltd., 2024) after a 214-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Feb 10, 2026
- Review
- 214 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K920064 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 5 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- 4 generations backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- 3 generations backK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
- 2 generations backK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
- 1 generation backK240095 CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model…Shanghai Care US Medical Product Co., Ltd. · 2024
- This deviceK252175 LANDR Contact LENS CaseFourth Axis, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −5 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| −4 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| −3 | K093377 | Polaris Contact Lens Case | Reliance Design & Manufacturing Corp. | 2010 | — |
| −2 | K120904 | Polaris Dial-a-Date Contact Lens Case | Reliance Design & Manufacture Corp. | 2012 | — |
| −1 | K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. | 2024 | — |
| 0 (this device) | K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Summary page 8…nce: The following table shows the similarities and differences between the predicate and subject devices. Description LANDR (K252175) CAREUS (K240095) SE Comparision Intended Use The LANDR Contact Lens “CAREUS Contact Lens SE… | 2024 |
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 34 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K240095.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The LANDR Contact Lens Case is designed for storing soft (hydrophilic), rigid gas-permeable, and/or rigid contact lenses. It is only for use during storage with chemical disinfection and should not be used during heat disinfection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252175: LANDR 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/K252175
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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