# K191266: VitalScan ANS

- Pathway: 510(k) (Traditional)
- Applicant: Medeia, Inc.
- Decided: Jan 15, 2020 after 250 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: 5 generations back to K853124 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083735: Ansha Autonomic Nervous System Health Assessment Plus, Medtechs, LLC (2009) Summary page 4.
- K101983: Critical Care Assessment, Critical Patient Care, Inc. (2010) Summary page 4.
- K172655: Automated ankle brachial pressure index measuring device, Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. (2018) Summary page 4.

## Indications for use
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems. VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD). The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals. The physician has the responsibility of interpreting the significance of the resulting data.

Source page: https://510kreport.com/device/K191266
Methodology: https://510kreport.com/methodology