# K143094: QuantaFlo

- Pathway: 510(k) (Traditional)
- Applicant: Semler Scientific, Inc.
- Decided: Mar 5, 2015 after 128 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944495 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093192: Flochec Photo Plethysmographic Device, Advanced Vascular Dynamics (2010) Summary page 4.

## Indications for use
QuantaFlo is intended to aid clinicians in the diagnosis and monitoring of Peripheral Arterial Disease. It provides bilateral, non-invasive physiologic studies of the upper and lower extremity arteries, using volume plethysmography of the posterior tibial and anterior tibial/dorsalis pedis arterial distributions. Additionally, QuantaFlo may be used to perform bilateral, non-invasive physiologic studies of the upper and lower extremity arteries with provocative functional maneuvers. The device is for adult use and not for pediatric or fetal use.

Source page: https://510kreport.com/device/K143094
Methodology: https://510kreport.com/methodology