# K102165: Sterile Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Cachet Pharmaceuticals Pvt., Ltd.
- Decided: Jan 19, 2011 after 170 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P850045: Blairex Sterile Saline Solution, Blairex Laboratories, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P850045/S001 (Jun 27, 1986). Summary page 1.

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

Source page: https://510kreport.com/device/K102165
Methodology: https://510kreport.com/methodology