# FQH: Lavage, Jet

- Device class: 2; regulation: 21 CFR 880.5475; FDA's rule: 510(k) exempt
- FDA decisions: 53
- 510(k) review time 2021–2025: median 136 days (middle half 86–414)
- Recalls: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 3
- 2011: 2
- 2012: 1
- 2015: 1
- 2016: 1
- 2020: 3
- 2021: 1
- 2022: 4
- 2023: 3
- 2026: 2

## Most-cited predicates
- K161165: Next Science Irrigation Solution (2016), cited by 4
- K060782: Versajet Hydrosurgery System and Handpiece (2006), cited by 3
- K210536: Irrisept Antimicrobial Wound Lavage (2021), cited by 3
- K072404: Erbe Erbejet 2 System (2007), cited by 3
- K012464: Helix Hydro-Jet (2001), cited by 3
- K221504: BD Surgiphor™ Antimicrobial Irrigation System (2022), cited by 2
- K080779: Irrisept Wound Cleansing System (2009), cited by 2
- K011612: Modification to Hydrocision Debridement System (2001), cited by 2
- K022613: Helix Hydro-Jet (2002), cited by 2
- K991383: Hydrocision Debdridement System (2000), cited by 2

Source page: https://510kreport.com/product-code/FQH
Data by year (CSV): https://510kreport.com/product-code/FQH.csv