# K240320: Patient Monitor (RespArray)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jun 28, 2024 after 147 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
Longest line of descent: 34 generations back to K941811 (1994). 230 ancestors in all.
No later device cites it as a predicate yet.
1 of 231 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220308: Patient Monitor: RespArray, Edan Instruments, Inc. (2022) Summary page 6.

## Indications for use
The RespArrayr patient monitor is intended to be used for monitoring, storing, reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitor is for prescription use only. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2). The arrhythmia detection and ST Segment analysis are intended for adult patients. The SpO2 (Nellcor TM) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion and no motion conditions, and in patients who are well or poorly perfused. The MicrostreamTM capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR). The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up. The monitors are not intended for MRI environments.

Source page: https://510kreport.com/device/K240320
Methodology: https://510kreport.com/methodology