# K133222: Saad Patient Monitor (SPM)

- Pathway: 510(k) (Traditional)
- Applicant: Hanin Medical Services Co., Ltd.
- Decided: Aug 6, 2014 after 292 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SPM is indicated for monitoring heart rate, invasive and non-invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations. SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatric populations only (not intended for use on neonatal populations). SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, either directly or via the Saad Patient Monitoring network (SPMS). SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments. MR Environment Compatibility Statement: The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).

Source page: https://510kreport.com/device/K133222
Methodology: https://510kreport.com/methodology