# K213616: BD Surgiphor Antimicrobial Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 23, 2022 after 128 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: 12 generations back to K914579 (1992). 56 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210536: Irrisept Antimicrobial Wound Lavage, Irrimax Corporation (2021) Summary page 4.
- K202071: SURGIPHOR Wound Irrigation System, Orthophor, LLC (2020) Summary page 4.

## Most influential descendants
- K221504: BD Surgiphor™ Antimicrobial Irrigation System (2022), 2 descendants of its own
- K253996: BD Surgiphor™ Antimicrobial Irrigation System (910110) (2026), 0 descendants of its own
- K253445: BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (2026), 0 descendants of its own

## Indications for use
BD Surgiphor ™ Antimicrobial Irrigation System is intended to mechanicallly loosen and remove debris, and foreign materials, including microorganisms, from wounds.

Source page: https://510kreport.com/device/K213616
Methodology: https://510kreport.com/methodology