510(k) · Cleared
ClearedContact Lens Case (multiple brand name)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danyang Chanxin Glasses Cases Factory · LRX Case, Contact Lens
Cleared on Jun 7, 2016 as substantially equivalent to K071081 (Ningbo Kaida Rubber and Plastic Technology Co., LT, 2007) after a 155-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jun 7, 2016
- Review
- 155 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920064 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 2 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- 1 generation backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- This deviceK160005 Contact Lens Case (multiple brand name)Danyang Chanxin Glasses Cases Factory · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −2 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| −1 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| 0 (this device) | K160005 | Contact Lens Case (multiple brand name) | Danyang Chanxin Glasses Cases Factory | 2016 | — |
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 |
|---|---|---|---|
| * | K071081 | Contact Lens CaseSummary page 5…1/5 K160005 III. PREDICATE DEVICE Contact Lens Case(K071081) This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVI… | 2007 |
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 24 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K071081.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic)
contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160005: Contact Lens Case (multiple brand name).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160005
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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