# K251114: FloPatch FP120

- Pathway: 510(k) (Traditional)
- Applicant: Flosonics Medical
- Decided: Jun 20, 2025 after 70 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930200 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223843: FloPatch FP120, Flosonics Medical (2023) Summary page 6.

## Most influential descendants
- K252810: FloPatch FP120 (2026), 0 descendants of its own

## Indications for use
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.

Source page: https://510kreport.com/device/K251114
Methodology: https://510kreport.com/methodology