# K093367: Sterile Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Cachet Pharmaceuticals Pvt., Ltd.
- Decided: Sep 10, 2010 after 316 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: 1 generation back to K002319 (2000). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002319: Purilens Saline Solution, Purilens, Inc. (2000) Summary page 1.
- K042562: Lens Plus Rewetting Drops, Advanced Medical Optics, Inc. (2005) Summary page 1.
- 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 3.

## Most influential descendants
- K110221: Eye-Cept Sterile Saline Solution (2011), 8 descendants of its own
- K151768: Menicon Saline Rinse Solution (2015), 6 descendants of its own
- K170483: Bausch + Lomb Sensitive Eyes Plus Saline Solution (2017), 2 descendants of its own
- K201069: VibrantVue Scleral Saline (2020), 1 descendant of its own
- K193441: Aqua Naina Sterile Saline Solution (2020), 1 descendant of its own

## Indications for use
Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.

Source page: https://510kreport.com/device/K093367
Methodology: https://510kreport.com/methodology