# K050919: Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P, AN4322P & AN3423P

- Pathway: 510(k) (Abbreviated)
- Applicant: Analogic Corp.
- Decided: Jun 14, 2005 after 63 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 9 generations back to K941811 (1994). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030931: C3 Patient Monitor, Analogic Corp. (2003) Summary page 2.
- K041434: C3 and Lifegard Icg Impedance Cardiography Monitors, Analogic Corp. (2004) Summary page 2.
- K023871: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology, Philips Medical Systems (2002) Summary page 3.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 3.
- K040113: Sandman SD20 Amplifier, Eb Neuro S.P.A. (2004) Summary page 3.
- (no number) Vasotrac APM205A: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K001152: Continuous non-invasive blood pressure Multi-parameter patient monitoring system. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434. The purpose and function of the LIFEGARD lI Family is to monitor: * ECG * Heart rate • Non-invasive blood pressure (NIBP) * Functional arterial oxygen saturation (SpO2) * Respiration rate • Temperature and * End-tidal carbon dioxide (EtCO 2) * Impedance Cardiography (ICG) * Arrhythmia with ST segment detection * Continuous non-invasive blood pressure (CNIBP) The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below: * Height: 4 ft- 7 ft- 6 in (122- 229 cm) • Weight: 67 -350 lbs (30- 159 Kg) The CNIIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

Source page: https://510kreport.com/device/K050919
Methodology: https://510kreport.com/methodology