# K130740: Nightingale Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Zoe Medical, Inc.
- Decided: Jul 23, 2013 after 126 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: 10 generations back to K962603 (1997). 71 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 75 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software, Spacelabs Healthcare Medical Equipment (Suzhou) CO (2009) Summary page 2.

## Most influential descendants
- K152043: Diagnostic Station DS20 (2016), 1 descendant of its own
- K170182: Cardiovit FT-1 (2017), 0 descendants of its own
- K150620: 740 Select (2015), 0 descendants of its own

## Indications for use
The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations. The Zoe Medical Nightingale Monitoring System facilitates the monitoring of: - ECG - Impedance respiration - Non-Invasive blood pressure - Invasive blood pressure - Body temperature - Functional arterial oxygen saturation (SPO2) - End-tidal & inspired 002 The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Source page: https://510kreport.com/device/K130740
Methodology: https://510kreport.com/methodology