510(k) · Cleared
ClearedEye-Cept Sterile Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optics Laboratory, Inc. · LPN Accessories, Soft Lens Products
Cleared on Nov 1, 2011 as substantially equivalent to K093367 (Cachet Pharmaceuticals Pvt., Ltd., 2010) and 1 other predicate after a 280-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it.
- Decided
- Nov 1, 2011
- Review
- 280 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002319 (2000). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- 1 generation backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- This deviceK110221 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 · cites it directly · 1 of its ownK193441 Aqua Naina Sterile Saline SolutionChemtex USA, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK221263 Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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 · cites it directly1descendant
- K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| −1 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| 0 (this device) | 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 | — |
| +1 | K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | 2020 | — |
| +2 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K093367 | Sterile Saline SolutionSummary page 1…s care products (21 CR 886.5928, Product Code LPN) D. Predicate Device(s): Cachet Saline Solution - K093367 Alcon (formerly Cooper) Unisol® Saline Solution - P790011 E. Device Description: Eye-Cept*'Sterile Saline Solution is provided… | 2010 |
| * | P790011 | Unisol FDA lists this PMA only through its supplements; the earliest we hold is P790011/S001 (Dec 31, 1980). Summary page 1…LPN) D. Predicate Device(s): Cachet Saline Solution - K093367 Alcon (formerly Cooper) Unisol® Saline Solution - P790011 E. Device Description: Eye-Cept*'Sterile Saline Solution is provided in single use, carry-on… |
What descends from it? (8)
3 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 11 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151768 (Menicon Co, Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K093367.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Eye-Cept® Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110221 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110221: Eye-Cept Sterile Saline Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110221
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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