# K954826: Disetronic Multifuse Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: May 24, 1996 after 217 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
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) Disetronic Panomat Infusion Pump: named in the summary without a submission number
- (no number) Disetronic Dolomat Infusion Pump: named in the summary without a submission number
- (no number) SIMS Deltec CADD-PLUS: named in the summary without a submission number
- (no number) SIMS Deltec CADD-PCA: named in the summary without a submission number
- (no number) SIMS Deltec CADD-TPN: named in the summary without a submission number

## Indications for use
The Disetronic Multifuse Pump with its accessories is intended for the controlled delivery of parenteral fluids, including patient controlled analgesia (PCA), in both the hospital and home care environments.

Source page: https://510kreport.com/device/K954826
Methodology: https://510kreport.com/methodology