# K073323: SA-3000P

- Pathway: 510(k) (Traditional)
- Applicant: Medicore Co., Ltd.
- Decided: Nov 29, 2007 after 2 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.
3 later devices descend from it; 1 cites it directly.
0 of 6 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 1.

## Most influential descendants
- K083735: Ansha Autonomic Nervous System Health Assessment Plus (2009), 2 descendants of its own
- K101983: Critical Care Assessment (2010), 1 descendant of its own
- K191266: VitalScan ANS (2020), 0 descendants of its own

## 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/K073323
Methodology: https://510kreport.com/methodology