# K990496: Anesflow-Dual Drip IV Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Design Assoc.
- Decided: Jul 1, 1999 after 134 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Additiv®; Primary IV Set (60 drops/ml) with 3 Injection Sites: named in the summary without a submission number
- (no number) Additiv®; Primary IV Set (15 drops/ml) with Check Valve and 2 Injection Sites: named in the summary without a submission number
- (no number) Anesthesia I.V. Set (15 drops/ml) vented set with in-line backcheck valve, three Y-injection sites, two four-way stopcocks, and male luer slip adapter: named in the summary without a submission number

## Indications for use
An intravascular administration set intended to administer fluids from a fluid container (IV bag) to a patient's vascular system through a needle or catheter inserted into a vein.

Source page: https://510kreport.com/device/K990496
Methodology: https://510kreport.com/methodology