510(k) · Cleared
ClearedSterile Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cachet Pharmaceuticals Pvt., Ltd. · LPN Accessories, Soft Lens Products
Cleared on Sep 10, 2010 as substantially equivalent to K002319 (Purilens, Inc., 2000) and 2 other predicates after a 316-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.
- Decided
- Sep 10, 2010
- Review
- 316 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K002319 (2000). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- This deviceK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK170483 Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017
- Descendant · 2 generations on · 1 of its ownK201069 VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK193441 Aqua Naina Sterile Saline SolutionChemtex USA, Inc. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K110221Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011 · cites it directly8descendants
- K151768Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015 · cites it directly6descendants
- K170483Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017 · 2 generations on2descendants
- K201069VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020 · 2 generations on1descendant
- K193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| 0 (this device) | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| +1 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| +1 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| +2 | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017 | — |
| +2 | K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | 2020 | — |
| +2 | K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | 2020 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K002319 | Purilens Saline SolutionSummary page 1…ilic) Contact Lens Solution Proprietary Name: Sterile Saline Solution 4. Leirallv Marketed Predicate Devices Purilens Saline Solution - K0023 19 Lens Plus Rewetting Drops - K042562 Unisol -P7900 1I Page 2 of 4 ===… | 2000 |
| * | K042562 | Lens Plus Rewetting DropsSummary page 1…ry Name: Sterile Saline Solution 4. Leirallv Marketed Predicate Devices Purilens Saline Solution - K0023 19 Lens Plus Rewetting Drops - K042562 Unisol -P7900 1I Page 2 of 4 Cachet… | 2005 |
| * | P790011 | Unisol FDA lists this PMA only through its supplements; the earliest we hold is P790011/S001 (Dec 31, 1980). Summary page 3…is substantially equivalent to currently cleared Purilens Saline Solution - K0023 19, Lens Plus Rewetting Drops -K042562, UnisdI- P790011 cleared for miarketing uinder 510 (K) for rinsing and wetting of soft (hydrophilic) contact… |
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?
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Sterile Saline Solution is indicated for rinsing and wetting of soft
(hydrophilic) contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093367: Sterile 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/K093367
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