510(k) · Cleared
ClearedPurilens Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Purilens, Inc. · LPN Accessories, Soft Lens Products
Cleared on Aug 30, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 30, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- Descendant · 2 generations on · 8 of its ownK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK170483 Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017
- Descendant · 3 generations on · 1 of its ownK201069 VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K093367Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010 · cites it directly9descendants
- K110221Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011 · 2 generations on8descendants
- K151768Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015 · 2 generations on6descendants
- K170483Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017 · 3 generations on2descendants
- K201069VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| +1 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| +2 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| +2 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| +3 | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017 | — |
| +3 | K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPN? 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 LPN device
- #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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?
- Of its descendants, K093367 (Cachet Pharmaceuticals Pvt., Ltd., 2010) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, 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 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K002319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002319: Purilens Saline Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002319
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026