510(k) · Cleared
ClearedMini VP1 (PL67_F); Mini VP1 (PL61_F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avizor S.A. · LRX Case, Contact Lens
Cleared on Aug 1, 2025 as substantially equivalent to K240095 (Shanghai Care US Medical Product Co., Ltd., 2024) after a 162-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 1, 2025
- Review
- 162 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 backK240095 CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model…Shanghai Care US Medical Product Co., Ltd. · 2024
- This deviceK250495 Mini VP1 (PL67_F); Mini VP1 (PL61_F)Avizor S.A. · 2025
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 | 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 | — |
| 0 (this device) | K250495 | Mini VP1 (PL67_F); Mini VP1 (PL61_F) | Avizor S.A. | 2025 | — |
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 |
|---|---|---|---|
| * | K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Summary page 5…ication Name: Case, Contact Lens Device Classification: 2 Regulation Number: 886.5928 Panel: Ophthalmic Product Code: LRX, LPN 3. Legally Marketed Predicate Device: K240095, “CAREUS Contact Lens Case”, manufactured by Shanghai Care Us Medical Product Co., Ltd. 4. Device Description: MINI VPl is a… | 2024 |
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 33 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.
- 1 other device also cites its predicate K240095.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250495: Mini VP1 (PL67_F); Mini VP1 (PL61_F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250495
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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