# K161165: Next Science Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Next Science, LLC
- Decided: Sep 7, 2016 after 135 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945802 (1995). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072876: Prontosan Wound Irrigation Solution, B.Braun Medical, Inc. (2008) Summary page 4.

## Most influential descendants
- K220759: Armis VeriCyn Wound Wash (2023), 0 descendants of its own
- K203446: TorrentX Wound Wash (2021), 0 descendants of its own
- K203835: MIS Solution (2021), 0 descendants of its own
- K192349: Bactisure Wound Lavage (2020), 0 descendants of its own

## Indications for use
Next Science Irrigation Solution is to be used with a jet lavage system and is indicated for use in cleansing and removal of debris, including microorganisms, from wounds.

Source page: https://510kreport.com/device/K161165
Methodology: https://510kreport.com/methodology
