# K023238: Mcpulse

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Co., Ltd.
- Decided: Feb 19, 2003 after 145 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: 1 generation back to K853124 (1985). 1 ancestor in all.
14 later devices descend from it; 6 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853124: Novametrix Pulse Oximeter, Model 500, Novametrix Medical Systems, Inc. (1985) Summary page 1.

## Most influential descendants
- K083229: E.S Teck ( Electro Sensor Teck) (2009), 5 descendants of its own
- K102442: E.S.O. (Electro Sensor Oxi) (2010), 4 descendants of its own
- K073323: SA-3000P (2007), 3 descendants of its own
- K160956: LD-Oxi system (2016), 2 descendants of its own
- K083735: Ansha Autonomic Nervous System Health Assessment Plus (2009), 2 descendants of its own

## Indications for use
The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.

Source page: https://510kreport.com/device/K023238
Methodology: https://510kreport.com/methodology