# K030307: Davol Arthrovent Outflow Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Feb 13, 2003 after 15 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
Longest line of descent: 1 generation back to K963648 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963648: Stryker Suction Regulator, Stryker Endoscopy (1996) Summary page 1.

## Indications for use
The Davol® ArthroVent™ Outflow Tubing is designed to control the amount of suction during arthroscopic procedures by controlling the amount of ambient air entering the outflow tubing set. It is for use with Davol’s HydroFlex-AD Arthroscopic Distention System (reference 0025800, 0025200, 0025210), Arthro-Flo High Flow Irrigator (reference 0015000), and Gravity In-Flow Tubing Sets (reference 0088220, 0088240, and 0037870).

Source page: https://510kreport.com/device/K030307
Methodology: https://510kreport.com/methodology