510(k) · Cleared
ClearedPolaris Dial-a-Date Contact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Design & Manufacture Corp. · LRX Case, Contact Lens
Cleared on Nov 26, 2012 as substantially equivalent to K093377 (Reliance Design & Manufacturing Corp., 2010) after a 245-day review. Its family tree reaches back 4 generations to 1992. 9 later devices descend from it.
- Decided
- Nov 26, 2012
- Review
- 245 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920064 (1992). 5 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK920064 Opti-Lens Contact Lens CaseRyder Intl. Corp. · 1992
- 3 generations backK042578 I-Promotions Contact Lens CaseI-Promotions, Inc. · 2005
- 2 generations backK071081 Contact Lens CaseNingbo Kaida Rubber and Plastic Technology Co., LT · 2007
- 1 generation backK093377 Polaris Contact Lens CaseReliance Design & Manufacturing Corp. · 2010
- This deviceK120904 Polaris Dial-a-Date Contact Lens CaseReliance Design & Manufacture Corp. · 2012
- Descendant · cites it directly · 5 of its ownK130930 Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK240095 CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model…Shanghai Care US Medical Product Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK142717 Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact…Ni Hau Industrial Co., Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK162869 Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK252175 LANDR Contact LENS CaseFourth Axis, LLC · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130930Owl Contact Lens Cases, Dog Contact Lens CasesNingbo Lishunda Electronics Co., Ltd. · 2014 · cites it directly5descendants
- K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd. · 2024 · cites it directly2descendants
- K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye…Ni Hau Industrial Co., Ltd. · 2015 · 2 generations on2descendants
- K162869Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd. · 2016 · 3 generations on1descendant
- K252175LANDR Contact LENS CaseFourth Axis, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920064 | Opti-Lens Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −3 | K042578 | I-Promotions Contact Lens Case | I-Promotions, Inc. | 2005 | — |
| −2 | K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | 2007 | — |
| −1 | K093377 | Polaris Contact Lens Case | Reliance Design & Manufacturing Corp. | 2010 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
| +2 | K142717 | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case… | Ni Hau Industrial Co., Ltd. | 2015 | — |
| +3 | K162869 | Contact Lens Case | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 2016 | — |
| +2 | K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | 2026 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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 |
|---|---|---|---|
| * | K093377 | Polaris Contact Lens CaseSummary page 3…Dial-a-Date (202) Contact Lens Case ()Number 5 K093377 Pending Classification Ophthalmic… | 2010 |
What descends from it? (9)
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 20 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K130930 (Ningbo Lishunda Electronics Co., Ltd., 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K093377.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Polaris 'Dial-A-Date' is a contact lens case for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses. Use 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/K120904 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120904: Polaris Dial-a-Date Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120904
Report an extraction error
Are you the manufacturer?
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