# K110374: Max Pulse System

- Pathway: 510(k) (Traditional)
- Applicant: Medicore Co., Ltd.
- Decided: Jun 13, 2011 after 124 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 2.

## Indications for use
The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices

Source page: https://510kreport.com/device/K110374
Methodology: https://510kreport.com/methodology