# K002319: Purilens Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Purilens, Inc.
- Decided: Aug 30, 2000 after 30 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.
11 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093367: Sterile Saline Solution (2010), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K002319
Methodology: https://510kreport.com/methodology