# K191388: FloPatch (FP110)

- Pathway: 510(k) (Traditional)
- Applicant: Flosonics Medical (R/A 1929803 Ontario Corp.)
- Decided: Jun 21, 2019 after 28 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). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140579: Ultrasonic Pocket Doppler, Edan Instruments, Inc. (2015) Summary page 5.

## Most influential descendants
- K242487: Laminar P1 (LDH-HW-001) (2024), 0 descendants of its own

## Indications for use
The FloPatch(FP110) is intended for the detection of blood flow in peripheral vasculature. 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 only.

Source page: https://510kreport.com/device/K191388
Methodology: https://510kreport.com/methodology