# K200567: ASI Plethysmogrpah Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Arterial Stiffness, Inc.
- Decided: Feb 26, 2021 after 359 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 K853124 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023238: Mcpulse, Meridian Co., Ltd. (2003) Summary page 4.
- K853124: Novametrix Pulse Oximeter, Model 500, Novametrix Medical Systems, Inc. (1985) Summary page 4.

## Indications for use
The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.

Source page: https://510kreport.com/device/K200567
Methodology: https://510kreport.com/methodology