510(k) · Cleared

Cleared

NPB3900 Series Patient Monitors

K980411510(k) TraditionalCleared Aug 20, 1998198-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 Aug 20, 1998 as substantially equivalent to K962424 (Analogic Corp., 1996) and 2 other predicates after a 198-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Aug 20, 1998
Review: 198 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K943695 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
This deviceK980411 NPB3900 Series Patient MonitorsAnalogic Corp. · 1998
Descendant · cites it directly · 0 of its ownK041376 C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054…Analogic Corp. · 2004

Most influential descendants

Showing 1 of 1 · See all

K041376C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer for…Analogic Corp. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943695	Suretemp	Advanced Bioresearch Assoc.	1995	—
0 (this device)	K980411	NPB3900 Series Patient Monitors	Analogic Corp.	1998	—
+1	K041376	C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional…	Analogic Corp.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K980411, 1995–2004Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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 …ccessories PREDICATE DEVICES The legally marketed devices to which equivalence is being claimed are: e NPB-4000 patient monitor, manufactured by Analogic Corporation (K962424). e SureTemp Thermometer Model 679, manufactured by Welch Allyn, Inc. (K943695 and K964643) Analogic Corporation January 30, 19…	Analogic Corp.	1996	—
*	K943695	Suretemp Summary page 1 …is being claimed are: e NPB-4000 patient monitor, manufactured by Analogic Corporation (K962424). e SureTemp Thermometer Model 679, manufactured by Welch Allyn, Inc. (K943695 and K964643) Analogic Corporation January 30, 1998 NPB3900 Series Patient Monitors 510(k) Appendix F, Page 1 of 4 === Page 2 ==…	Advanced Bioresearch Assoc.	1995	—
*	K964643	Suretemp Summary page 1 …aimed are: e NPB-4000 patient monitor, manufactured by Analogic Corporation (K962424). e SureTemp Thermometer Model 679, manufactured by Welch Allyn, Inc. (K943695 and K964643) Analogic Corporation January 30, 1998 NPB3900 Series Patient Monitors 510(k) Appendix F, Page 1 of 4 DEVICE DES…	Diatek Instruments, Inc.	1997	—

Also cleared against K962424: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041376	C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer for…	Analogic Corp.	2004	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?

None of the 3 ancestors has a recall.
Of its descendants, K041376 (Analogic Corp., 2004) has gone furthest, with 0 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 NPB3900 Series Patient Monitors are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure, (systolic, diastolic, and mean arterial pressure), functional arterial oxygen saturation, and temperature for adult and pediatric patients in all hospital areas and hospital type facilities and for patient transport in the hospital and in ambulances.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980411 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980411: NPB3900 Series Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980411

Report an extraction error

Are you the manufacturer?

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