510(k) · Cleared
ClearedLifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P, AN4322P & AN3423P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analogic Corp. · DSI Detector And Alarm, Arrhythmia
Cleared on Jun 14, 2005 as substantially equivalent to K030931 (Analogic Corp., 2003) and 4 other predicates after a 63-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jun 14, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K941811 (1994). 66 ancestors in all, the oldest K872781 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 2 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 1 generation backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- This deviceK050919 Lifegard II Family Multi-Function Patient Monitor, Models AN4320…Analogic Corp. · 2005
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 4 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 3 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 2 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 1 generation backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- This deviceK050919 Lifegard II Family Multi-Function Patient Monitor, Models AN4320…Analogic Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −4 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −3 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −2 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −1 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| 0 (this device) | K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P… | Analogic Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030931 | C3 Patient MonitorSummary page 2…Predicate Devices: The legally marketed devices to which equivalence is being claimed are: The C3 Patient Monitors cleared under Premarket Notification K030931 and K041434. * The Impedance Cardiography (ICG) parameter incorporated in the LIFEGARD II Famil… | 2003 |
| * | K041434 | C3 and Lifegard Icg Impedance Cardiography MonitorsSummary page 2…e Devices: The legally marketed devices to which equivalence is being claimed are: The C3 Patient Monitors cleared under Premarket Notification K030931 and K041434. * The Impedance Cardiography (ICG) parameter incorporated in the LIFEGARD II Family is identic… | 2004 |
| * | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Summary page 3…D-2 The M3046A (M2/M3/M4) Compact Portable Patient Monitor device cleared under K023871. This predicate device was chosen specifically for the arrhythmia with ST segment indication. The continuous non-… | 2002 |
| 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 | |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 3…ical technology of the predicate device. The Pulse Oximeter, Sensors and Cables with accessories and Physiological Signal Amplifier cleared under K012891and K040113, respectively. The technology as cleared in K012891 and K040113 is identical to the technology incorporated in… | 2002 |
| * | K040113 | Sandman SD20 AmplifierSummary page 3…logy of the predicate device. The Pulse Oximeter, Sensors and Cables with accessories and Physiological Signal Amplifier cleared under K012891and K040113, respectively. The technology as cleared in K012891 and K040113 is identical to the technology incorporated in the LIFEGA… | 2004 |
| * | — | Vasotrac APM205A Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 5 of the 66 ancestors have a recall of any class.
- 2 other devices also cite its predicate K030931.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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 •…
Read the full statement (210 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050919: Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P, AN4322P & AN3423P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050919
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026