# K223843: FloPatch FP120

- Pathway: 510(k) (Traditional)
- Applicant: Flosonics Medical
- Decided: May 3, 2023 after 132 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930200 (1994). 5 ancestors in all.
2 later devices descend 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)
- K222242: FloPatch FP120, Flosonics Medical (2022) Summary page 5.

## Most influential descendants
- K251114: FloPatch FP120 (2025), 1 descendant of its own
- K252810: FloPatch FP120 (2026), 0 descendants of its own

## Recalls of this device
- Aug 7, 2025 · Class III · Z-2517-2025: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

## Indications for use
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode. 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/K223843
Methodology: https://510kreport.com/methodology