# K132077: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Apr 23, 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
Longest line of descent: 30 generations back to K941811 (1994). 217 ancestors in all.
No later device cites it as a predicate yet.
1 of 218 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120173: Patient Monitor, Edan Instruments, Inc. (2012) Summary page 5.

## Indications for use
This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (Sp02), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired C02, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Source page: https://510kreport.com/device/K132077
Methodology: https://510kreport.com/methodology