# K984441: Kvo Check Valve Accessory, Model EV-0001

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Feb 22, 1999 after 70 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) B. Braun Low Pressure Check Valve: named in the summary without a submission number
- (no number) Medex, Inc. Check Valve: named in the summary without a submission number

## Most influential descendants
- K011888: Pressure Activated Check Valve (2001), 0 descendants of its own

## Indications for use
The KVO Accessory is intended to allow fluid flow in one direction and stop, or check, fluid flow in the opposite direction. The KVO Accessory is intended to be used with the I-Flow One-Step KVO infusion pump.

Source page: https://510kreport.com/device/K984441
Methodology: https://510kreport.com/methodology