# K191745: Medtronic Commander Flex

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Care Management Services
- Decided: May 15, 2020 after 319 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K864318 (1987). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053303: Cardiocom Commander Iii, Cardiocom, LLC (2005) Summary page 4.
- K091821: Commander 111, Model CD300-CD399, Cardiocom, LLC (2009) Summary page 4.
- K122285: Tablet Commander, Cardiocom, LLC (2012) Summary page 4.

## Indications for use
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.

Source page: https://510kreport.com/device/K191745
Methodology: https://510kreport.com/methodology