510(k) · Cleared

Cleared

C3 Patient Monitor

K030931510(k) SpecialCleared May 9, 200345-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Analogic Corp. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 9, 2003 as substantially equivalent to K962424 (Analogic Corp., 1996) after a 45-day review. Its family tree reaches back 1 generation to 1996. 13 later devices descend from it.

Decided: May 9, 2003
Review: 45 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962424 (1996). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK962424 NPB-4000Analogic Corp. · 1996
This deviceK030931 C3 Patient MonitorAnalogic Corp. · 2003
Descendant · cites it directly · 11 of its ownK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
Descendant · 2 generations on · 4 of its ownK060387 Physioflow SystemVasocom, Inc. · 2008
Descendant · 2 generations on · 4 of its ownK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
Descendant · 3 generations on · 3 of its ownK103283 Physioflow EnduroVasocom, Inc. · 2010
Descendant · 4 generations on · 2 of its ownK140102 Physioflow Q-LinkVasocom, Inc. · 2014

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2004high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 13 · See all

K041434C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004 · cites it directly11descendants
K060387Physioflow SystemVasocom, Inc. · 2008 · 2 generations on4descendants
K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007 · 2 generations on4descendants
K103283Physioflow EnduroVasocom, Inc. · 2010 · 3 generations on3descendants
K140102Physioflow Q-LinkVasocom, Inc. · 2014 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962424	NPB-4000	Analogic Corp.	1996	—
0 (this device)	K030931	C3 Patient Monitor	Analogic Corp.	2003	—
+1	K041434	C3 and Lifegard Icg Impedance Cardiography Monitors	Analogic Corp.	2004	—
+2	K060387	Physioflow System	Vasocom, Inc.	2008	—
+2	K070156	Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100	Cardiodynamics International Corp.	2007	—
+3	K103283	Physioflow Enduro	Vasocom, Inc.	2010	—
+4	K140102	Physioflow Q-Link	Vasocom, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2014	1	0
2017	1	0
2018	2	0

FIG. 1 — Lineage of K030931, 1996–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K962424	NPB-4000 Summary page 1 …legally marketed devices to which equivalence is being claimed is: The NFB-4000 Patient Monitor that was cleared under Premarket Notification K962424. DEVICE DESCRIPTION: The C3 Patient Monitor is a compact, lightweight monitor for measuring,…	Analogic Corp.	1996	—

Also cleared against K962424: 2 other devices →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041434	C3 and Lifegard Icg Impedance Cardiography Monitors	Analogic Corp.	2004	11
K051903	Fetalgard Lite-Nibp, Model FGL-Nibp	Analogic Corporation	2005	0
K050919	Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…	Analogic Corp.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K041434 (Analogic Corp., 2004) has gone furthest, with 11 descendants of its own.
2 other devices also cite its predicate K962424.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030931: C3 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030931

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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