510(k) · Cleared
ClearedEye Care Cure Contact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eye Care and Cure · LRX Case, Contact Lens
Cleared on Dec 5, 2011 as substantially equivalent to K042578 (I-Promotions, Inc., 2005) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Dec 5, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920064 (1992). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 1 generation backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- This deviceK112832 Eye Care Cure Contact Lens CaseEye Care and Cure · 2011
- Descendant · cites it directly · 0 of its ownK231123 Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −1 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| 0 (this device) | K112832 | Eye Care Cure Contact Lens Case | Eye Care and Cure | 2011 | — |
| +1 | K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens… | Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K042578 | I-Promotions Contact Lens CaseSummary page 1…vices: The following devices have been identified as the predicate devices for the Eye Care and Cure contact lens case: Predicate Device: i-Promotions Contact Lens Case (K042578) i-Promotions, Inc. 9522 Gravois Rd. St. Louis, MO 63123 Predicate Device: Pelican Contact Lens Case (K030987) Pelican Products,… | 2005 |
| * | K030987 | Contact Lens Storage CaseSummary page 1…ns case: Predicate Device: i-Promotions Contact Lens Case (K042578) i-Promotions, Inc. 9522 Gravois Rd. St. Louis, MO 63123 Predicate Device: Pelican Contact Lens Case (K030987) Pelican Products, Inc. 2248 Highway 43 North Pelhatchie, MS 39145 Non-Sterile: The Eye Care and Cure Contact Lens Case is a non… | 2003 |
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 |
|---|---|---|---|
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -… | 2023 | 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 19 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231123 (Phoenix Innovative Healthcare Manufacturers Pvt., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K042578.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112832: Eye Care Cure 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/K112832
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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