510(k) · Cleared
ClearedVibrantVue Scleral Saline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dry Eye Innovations, LLC · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on Jul 31, 2020 as substantially equivalent to K151768 (Menicon Co, Ltd., 2015) after a 100-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jul 31, 2020
- Review
- 100 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002319 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- 3 generations backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- 2 generations backK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- 1 generation backK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- This deviceK201069 VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020
- Descendant · cites it directly · 0 of its ownK221263 Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| −3 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| −2 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| −1 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| 0 (this device) | K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | 2020 | — |
| +1 | K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 MRC? 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 MRC device
- #1 K251876 cleadew GP hydra onescore 10.8 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K151768 | Menicon Saline Rinse SolutionSummary page 5…indications to the following predicate device: x “Menicon Saline Rinse Solution” By Menicon Co., Ltd. 510(k) number: K151768 Device Classification: II IV. DEVICE DESCRIPTION The VibrantVue Scleral Saline is a sterile, preserva… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221263 | Aqua Naina Plus Sterile Saline Solution | 2022 | 0 |
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 4.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K221263 (Chemtex USA, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K151768.
How does its category compare?
All MRC devicesMRC Products, Contact Lens Care, Rigid Gas Permeable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MRC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRC
51in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRC
72in 2025
MAUDE reports naming product code MRC, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 51 | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 72 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VibrantVue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
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/K201069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K201069: VibrantVue Scleral Saline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K201069
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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