# K003345: Aosept Plus Cleaning and Disinfecting Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Mar 26, 2001 after 152 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.
8 later devices descend from it; 6 cite it directly.
0 of 9 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
- K013512: Aosept Clear Care Cleaning and Disinfecting Solution (2001), 7 descendants of its own
- K142284: Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde (2015), 3 descendants of its own
- K162597: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (2016), 2 descendants of its own
- K191872: Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (2020), 1 descendant of its own
- K173538: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (2017), 1 descendant of its own

Source page: https://510kreport.com/device/K003345
Methodology: https://510kreport.com/methodology