510(k) · Cleared
ClearedContact Lens Storage Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelican Products · LRX Case, Contact Lens
Cleared on Jun 12, 2003 after a 76-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Jun 12, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 3 citing it directly.
- This deviceK030987 Contact Lens Storage CasePelican Products · 2003
- Descendant · cites it directly · 23 of its ownK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- Descendant · 2 generations on · 17 of its ownK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- Descendant · 3 generations on · 11 of its ownK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
- Descendant · 4 generations on · 9 of its ownK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
- Descendant · 5 generations on · 5 of its ownK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K042578I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005 · cites it directly23descendants
- K071081Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007 · 2 generations on17descendants
- K093377Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010 · 3 generations on11descendants
- K120904Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012 · 4 generations on9descendants
- K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030987 | Contact Lens Storage Case | Pelican Products | 2003 | — |
| +1 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| +2 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| +3 | K093377 | Polaris Contact Lens Case | Reliance Design & Manufacturing Corp. | 2010 | — |
| +4 | K120904 | Polaris Dial-a-Date Contact Lens Case | Reliance Design & Manufacture Corp. | 2012 | — |
| +5 | K130930 | Owl Contact Lens Cases, Dog Contact Lens Cases | Ningbo Lishunda Electronics Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.4 · 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 |
|---|---|---|---|
| * | — | Alcon Contact Lens Case Named without a submission number |
What descends from it? (25)
See all 253 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?
- Of its descendants, K042578 (I-Promotions, Inc., 2005) has gone furthest, with 23 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.
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?
Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Use during chemical disinfection only.
DO NOT USE WITH HEAT
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030987 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030987: Contact Lens Storage Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030987
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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