# K915566: Disetronic Panomat Pump

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Aug 7, 1992 after 239 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990259: Disetronic Multifuse Infusion Pump System (1999), 0 descendants of its own

## Recalls of this device
- May 17, 2004 · Not classified · Z-1228-04: Lack of assurance of sterility.
- May 17, 2004 · Not classified · Z-1227-04: Lack of assurance of sterility.

Source page: https://510kreport.com/device/K915566
Methodology: https://510kreport.com/methodology