QuantaFlo PAD Photoelectric Plethysmograph

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number00859433006024 UDI-DI	Date19 Aug 2016Listed	StatusListed GUDID: not in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK143094	Date5 Mar 2015Cleared	StatusActive

Official records

AccessGUDID record UDI-DI 00859433006024
FDA 510(k) database 510(k) number K143094

Across registries

2 registries list this device

FDA 510(k) K143094 decided 5 Mar 2015 Active
FDA GUDID UDI-DI 00859433006024 listed 19 Aug 2016 Listed

Timeline

2 dated events

5 Mar 2015 Cleared FDA 510(k) K143094
19 Aug 2016 Listed FDA GUDID 00859433006024

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name: Limb plethysmograph
Model / reference: 91-0010

Primary DI / UDI-DI: 00859433006024
510(k) Number: K143094
FDA product code: JOM
GMDN term: Limb plethysmograph

Device class: Class II
Regulation: 21 CFR Part 870.2780
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent
GUDID distribution status: Not in Commercial Distribution

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Flochec Photo Plethysmographic Device K093192 12 Feb 2010 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The QuantaFlo PAD Photoelectric Plethysmograph is a pneumatic, photoelectric device used for detecting Peripheral Arterial Disease (PAD). Classified as a plethysmograph, it measures blood flow and vascular function in the lower extremities to assess arterial health and identify early signs of PAD.

This device is intended for use in clinical or home settings and operates as a non-invasive, point-of-care tool. Supplied as a reusable medical instrument, it adheres to FDA 510(k) clearance under the classification of Device Class II (regulation number 870.2780). It requires proper calibration and maintenance in accordance with manufacturer guidelines to ensure accurate and reliable performance.

From the manufacturer

QuantaFlo is our flagship solution that allows providers to test for early signs of Peripheral Arterial Disease (PAD) in a clinical or home setting, in a matter of minutes, using any compatible device.

Source: semlerscientific.com

Semler Scientific provides medical technology and software enabling point-of-care testing for early chronic disease detection.

Source: semlerscientific.com

Devices cleared under K143094

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K143094
		UDI-DI	Size and differences
QuantaFlo 52-0100 Semler Scientific, Inc.	52-0100	00859433006123	Prescription: yes	On the market
QuantaFlo 91-0010 Semler Scientific, Inc.	91-0010	00859433006024	Prescription: yes	No longer on the market
QuantaFlo 91-0013 Semler Scientific, Inc.	91-0013	00859433006048	Prescription: yes	No longer on the market
QuantaFlo 91-0015 Semler Scientific, Inc.	91-0015	00859433006062	Prescription: no	On the market
QuantaFlo 91-0016 Semler Scientific, Inc.	91-0016	00859433006079	Prescription: yes	On the market

Similar devices

Other devices filed under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic).

Other devices from Semler Scientific, Inc.

QuantaFlo 91-0015

Class II
QuantaFlo 91-0016

Class II
QuantaFlo 52-0100

Class II

Properties

Prescription use
Serial number

Other properties (13, all answered No)