# K961975: Disetronic D-Modem

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Jan 30, 1997 after 255 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 K943952 (1995). 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)
- K943952: Disetronic D-Modem, Disetronic Medical Systems (1995) Summary page 1.

## Indications for use
The D-MODEM is Intended to facilitate telephonic communication between a Personal Computer (PC) and the Disetronic Infusion Pumps. The modified device adds the Disetronic Multifuse Infusion Pump to the list of compatible pumps.

Source page: https://510kreport.com/device/K961975
Methodology: https://510kreport.com/methodology