510(k) · Cleared
ClearedCAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Care US Medical Product Co., Ltd. · LRX Case, Contact Lens
Cleared on Oct 9, 2024 as substantially equivalent to K120904 (Reliance Design & Manufacture Corp., 2012) after a 271-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Oct 9, 2024
- Review
- 271 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K920064 (1992). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 4 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- 3 generations backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- 2 generations backK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
- 1 generation backK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
- This deviceK240095 CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model…Shanghai Care US Medical Product Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252175 LANDR Contact LENS CaseFourth Axis, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250495 Mini VP1 (PL67_F); Mini VP1 (PL61_F)Avizor S.A. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −4 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| −3 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| −2 | K093377 | Polaris Contact Lens Case | Reliance Design & Manufacturing Corp. | 2010 | — |
| −1 | K120904 | Polaris Dial-a-Date Contact Lens Case | Reliance Design & Manufacture Corp. | 2012 | — |
| 0 (this device) | 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 | — |
| +1 | K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | 2026 | — |
| +1 | K250495 | Mini VP1 (PL67_F); Mini VP1 (PL61_F) | Avizor S.A. | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 K252175 LANDR Contact LENS Casescore 12.3 · 6 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 |
|---|---|---|---|
| * | K120904 | Polaris Dial-a-Date Contact Lens CaseSummary page 5…2 Regulation Number: 21 CFR 886.5928 Panel: General Ophthalmic Product Code: LRX 5 Predicate Device Information: K120904, “The Polaris Dial-a-Date Contact Lens Case”, manufactured by “Reliance Design & Manufacture Corp.” in Tainan, Taiwan 6 Dev… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K252175 (Fourth Axis, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120904.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
“CAREUS Contact Lens Case” is a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240095: CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240095
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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