# K983321: Microfuse Dual Rate Infuser

- Pathway: 510(k) (Special)
- Applicant: Baxa Corp.
- Decided: Oct 6, 1998 after 14 days
- Product code: FRN (Pump, Infusion)
- 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
Longest line of descent: 1 generation back to K933506 (1994). 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)
- K933506: Syringe Infuser, Baxa Corp. (1994) Summary page 2.

## Indications for use
The Baxa Corporation MicroFuse™Dual Rate Infuser is intended to be used for the intermittent administration of I.V. medication.

Source page: https://510kreport.com/device/K983321
Methodology: https://510kreport.com/methodology