# K913028: Arthro-Flow Irrigation 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Oct 10, 1991 after 93 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041824: X-Treme Arthroscopic Pump and Shaver System (2005), 6 descendants of its own
- K050580: Smith & Nephew Intelijet Fluid Management Systems (2005), 2 descendants of its own
- K051326: Smith & Nephew 25 Fluid Management System (2005), 1 descendant of its own
- K171794: Smith & Nephew 25 Fluid Management System (2017), 0 descendants of its own
- K131191: 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K913028
Methodology: https://510kreport.com/methodology