# K251876: cleadew GP hydra one

- Pathway: 510(k) (Traditional)
- Applicant: Ophtecs Corporation
- Decided: Oct 9, 2025 after 113 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- 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 P850093/S003 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181627: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner, Bausch & Lomb, Incorporated (2018) Summary page 6.

## Indications for use
cleadew GP hydra one is indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Source page: https://510kreport.com/device/K251876
Methodology: https://510kreport.com/methodology