510(k) · Cleared

Cleared

NPB-4000

K962424510(k) TraditionalCleared Dec 20, 1996179-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 Dec 20, 1996 after a 179-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 311 devices in its family, counting itself, have a Class I recall. 310 later devices descend from it.

Decided: Dec 20, 1996
Review: 179 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 0

310 later devices descend from it, 3 citing it directly. 2 of the 311 devices in this family, counting this one, have a Class I recall.

This deviceK962424 NPB-4000Analogic Corp. · 1996
Descendant · cites it directly · 293 of its ownK012139 Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2002
Descendant · 2 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
Descendant · 2 generations on · 270 of its ownK040847 Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004
Descendant · 2 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
Descendant · 3 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 310 descendants. See all descendants

Descendants cleared per year

1998high 22 (2023) · low 0 (1999)2026

Class I recalls in this family

K133886 Perseus A5004 generations on · 2014
K230931 Atlan5 generations on · 2023

Most influential descendants

Showing 5 of 310 · See all

K012139Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2002 · cites it directly293descendants
K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on280descendants
K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004 · 2 generations on270descendants
K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 2 generations on251descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on249descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962424	NPB-4000	Analogic Corp.	1996	—
+1	K012139	Vamos Anesthetic Gas Monitor	Draeger Medical, Inc.	2002	—
+2	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…	Siemens Medical Solutions USA, Inc.	2003	—
+2	K040847	Modification to Vamos Anesthetic Gas Monitor	Draeger Medical, Inc.	2004	—
+2	K041956	Emg - Essential Gas Module, Model M1013A	Draeget Medical AG & Co. Kgaa	2004	—
+3	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2003	2	0
2004	9	0
2005	11	0
2006	14	0
2007	8	0
2008	6	0
2009	7	0
2010	10	0
2011	12	0
2012	10	0
2013	13	0
2014	14	1
2015	12	0
2016	13	0
2017	14	0
2018	18	0
2019	11	0
2020	11	0
2021	15	0
2022	20	0
2023	22	1
2024	18	0
2025	21	0
2026	17	0

FIG. 1 — Lineage of K962424, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (310)

See all 310

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

Number	Device	Applicant	Decided	Descendants
K012139	Vamos Anesthetic Gas Monitor	Draeger Medical, Inc.	2002	293
K030931	C3 Patient Monitor	Analogic Corp.	2003	13
K980411	NPB3900 Series Patient Monitors	Analogic Corp.	1998	1

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K133886Perseus A500Draeger Medical GmbH · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

Of its descendants, K012139 (Draeger Medical, Inc., 2002) has gone furthest, with 293 descendants of its own.

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	—

https://510kreport.com/device/K962424 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962424: NPB-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962424

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026