# K200160: 740 SafeSAT

- Pathway: 510(k) (Traditional)
- Applicant: Zoe Medical, Inc.
- Decided: Feb 15, 2021 after 390 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130411: 740 Select, Cas Medical Systems, Inc. (2013) Summary page 5.

## Indications for use
The 740 SafeSAT is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring and recording of adult and pediatric patients, excluding neonates. The Monitor features technology to facilitate the monitoring of non-invasive blood pressure, pulse rate and functional arterial oxygen saturation (SpO2) in a variety of clinical environments.

Source page: https://510kreport.com/device/K200160
Methodology: https://510kreport.com/methodology