# K030931: C3 Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Analogic Corp.
- Decided: May 9, 2003 after 45 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: 1 generation back to K962424 (1996). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962424: NPB-4000, Analogic Corp. (1996) Summary page 1.

## Most influential descendants
- K041434: C3 and Lifegard Icg Impedance Cardiography Monitors (2004), 11 descendants of its own
- K060387: Physioflow System (2008), 4 descendants of its own
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 (2007), 4 descendants of its own
- K103283: Physioflow Enduro (2010), 3 descendants of its own
- K140102: Physioflow Q-Link (2014), 2 descendants of its own

## Indications for use
The purpose and function of the C3 patient monitor is to monitor continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (Sp02), respiration rate, temperature and carbon dioxide (C02) for single patient use on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.

Source page: https://510kreport.com/device/K030931
Methodology: https://510kreport.com/methodology