# K252810: FloPatch FP120

- Pathway: 510(k) (Special)
- Applicant: Flosonics Medical
- Decided: Apr 24, 2026 after 233 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: 6 generations back to K930200 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251114: FloPatch FP120, Flosonics Medical (2025) Summary page 5.

## Indications for use
The FloPatch FP120 is a wireless, non-invasive Doppler ultrasound system indicated to aid medical professionals as an adjunctive assessment in performing Critical Care Ultrasonography (CCUS) for Targeted Volume Management (TVM). The FloPatch FP120 is indicated for use for the non-invasive assessment of blood flow in peripheral vasculature (including the carotid) in a target vessel. The device operates in a single mode, Continuous Wave (CW), providing quantitative flow metrics for arterial flow. 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/K252810
Methodology: https://510kreport.com/methodology