510(k) · Cleared
ClearedAqua Naina Sterile Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtex USA, Inc. · LPN Accessories, Soft Lens Products
Cleared on May 26, 2020 as substantially equivalent to K110221 (Optics Laboratory, Inc., 2011) and 2 other predicates after a 167-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- May 26, 2020
- Review
- 167 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002319 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- 2 generations backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- 1 generation backK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- This deviceK193441 Aqua Naina Sterile Saline SolutionChemtex USA, Inc. · 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 |
|---|---|---|---|---|---|
| −3 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| −2 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| −1 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| 0 (this device) | K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | 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 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 |
|---|---|---|---|
| * | K110221 | Eye-Cept Sterile Saline SolutionSummary page 4…886.5928 Product Code: LPN (3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed devices. Eye-Cept Sterile Saline Solution K110221 (Primary Predicate) Purilens Saline Solution – K002319 Unisol Saline Solution - P790011 (4) DESCRIPTION OF THE DEV… | 2011 |
| * | K002319 | Purilens Saline SolutionSummary page 4…bstantial equivalence is based on following legally marketed devices. Eye-Cept Sterile Saline Solution K110221 (Primary Predicate) Purilens Saline Solution – K002319 Unisol Saline Solution - P790011 (4) DESCRIPTION OF THE DEVICE: Aqua Naina Sterile Saline Solution is a sterile, p… | 2000 |
| * | P790011 | Unisol FDA lists this PMA only through its supplements; the earliest we hold is P790011/S001 (Dec 31, 1980). Summary page 4…wing legally marketed devices. Eye-Cept Sterile Saline Solution K110221 (Primary Predicate) Purilens Saline Solution – K002319 Unisol Saline Solution - P790011 (4) DESCRIPTION OF THE DEVICE: Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, c… |
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 4 companies; a new generation was cleared every 8.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K221263 (Chemtex USA, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110221.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193441: Aqua Naina 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/K193441
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