# K203835: MIS Solution

- Pathway: 510(k) (Traditional)
- Applicant: Next Science, LLC
- Decided: Apr 23, 2021 after 114 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945802 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161165: Next Science Irrigation Solution, Next Science, LLC (2016) Summary page 4.

## Indications for use
MIS Solution is indicated for use in cleansing and removal of debris, including microorganisms from wounds.

Source page: https://510kreport.com/device/K203835
Methodology: https://510kreport.com/methodology