510(k) · Cleared
ClearedContact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Link Plastic & Metal Industrial Co.,Ltd · LRX Case, Contact Lens
Cleared on Jul 14, 2017 as substantially equivalent to K130930 (Ningbo Lishunda Electronics Co., Ltd., 2014) after a 49-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jul 14, 2017
- Review
- 49 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 backK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014
- This deviceK171539 Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd · 2017
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 | K130930 | Owl Contact Lens Cases, Dog Contact Lens Cases | Ningbo Lishunda Electronics Co., Ltd. | 2014 | — |
| 0 (this device) | K171539 | Contact Lens Case | E-Link Plastic & Metal Industrial Co.,Ltd | 2017 | — |
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 |
|---|---|---|---|
| * | K130930 | Owl Contact Lens Cases, Dog Contact Lens CasesSummary page 5…formation Manufacturer Device Name 510(K) Number Ningbo Lishunda “OWL Contact Lens Cases” and “DOG K130930 Electronics Co.,Ltd Contact Lens Case” ( or other clients private labeling) 6. Dev… | 2014 |
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 25 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.
- 2 other devices also cite its predicate K130930.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Contact Lens Case is a device intended for 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/K171539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171539: 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/K171539
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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