# K192349: Bactisure Wound Lavage

- Pathway: 510(k) (Traditional)
- Applicant: Next Science, LLC
- Decided: Jan 23, 2020 after 147 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: 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
Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus or Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.

Source page: https://510kreport.com/device/K192349
Methodology: https://510kreport.com/methodology