# K040752: Dosi-Fuser

- Pathway: 510(k) (Traditional)
- Applicant: Leventon, S.A.
- Decided: Apr 7, 2004 after 14 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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) SINGLEDAY INFUSOR 2 ml./h: named in the summary without a submission number

## Indications for use
The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intra-arterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use.

Source page: https://510kreport.com/device/K040752
Methodology: https://510kreport.com/methodology