# K193441: Aqua Naina Sterile Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Chemtex USA, Inc.
- Decided: May 26, 2020 after 167 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002319 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110221: Eye-Cept Sterile Saline Solution, Optics Laboratory, Inc. (2011) Summary page 4.
- K002319: Purilens Saline Solution, Purilens, Inc. (2000) Summary page 4.
- P790011: Unisol, Wesley Jessen Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P790011/S001 (Dec 31, 1980). Summary page 4.

## Most influential descendants
- K221263: Aqua Naina Plus Sterile Saline Solution (2022), 0 descendants of its own

## Indications for use
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.

Source page: https://510kreport.com/device/K193441
Methodology: https://510kreport.com/methodology