# K151812: Patient Monitors Various Models

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jan 26, 2016 after 208 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: 17 generations back to K941811 (1994). 206 ancestors in all.
No later device cites it as a predicate yet.
1 of 207 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123900: Suresigns VM4, Suresigns VM6, Suresigns VM8, Philips Medical Systems (2013) Summary page 5.
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 5.
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 5.
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 5.
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O, Philips Medical Systems (2010) Summary page 6.

## Indications for use
The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal); Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia (Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult, Pediatric); ST segment Analysis (Adult); Contraindications: Not for transport outside the healthcare facility

Source page: https://510kreport.com/device/K151812
Methodology: https://510kreport.com/methodology