510(k) · Cleared

Cleared

HP M2376A Device Link System

K984194510(k) TraditionalCleared Apr 30, 1999158-day reviewClass II21 CFR 876.5820

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

Hewlett-Packard Co. · MQS System, Hemodialysis, Access Recirculation Monitoring

Cleared on Apr 30, 1999 as substantially equivalent to K923682 (Hewlett-Packard Co., 1992) after a 158-day review. Its family tree reaches back 1 generation to 1992. 79 later devices descend from it.

Decided: Apr 30, 1999
Review: 158 days
Class: Class II
Product code: MQS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923682 (1992). 79 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
This deviceK984194 HP M2376A Device Link SystemHewlett-Packard Co. · 1999
Descendant · cites it directly · 78 of its ownK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
Descendant · 2 generations on · 46 of its ownK100272 Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · Recalled
Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

1999high 7 (2020) · low 0 (2000)2026

Most influential descendants

Showing 5 of 79 · See all

K992636HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · cites it directly78descendants
K100272Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · 2 generations on46descendants
K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923682	Model M1032A Vuelink Interface Plug-in Module	Hewlett-Packard Co.	1992	—
0 (this device)	K984194	HP M2376A Device Link System	Hewlett-Packard Co.	1999	—
+1	K992636	HP Carevue 9000 Clinical Information System, Model M2331A	Hewlett-Packard Co.	1999	8
+2	K100272	Intellivue Clinical Information Portfolio	Philips Medical Systems	2010	2
+2	K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	—
+3	K122223	New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…	Philips Medizin Systeme Boeblingen GmbH	2013	—
+4	K151736	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boblingen GmbH	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	2	0
2006	1	0
2007	2	0
2008	2	0
2010	3	0
2011	5	0
2012	2	0
2013	4	0
2014	6	0
2015	4	0
2016	1	0
2017	4	0
2018	4	0
2019	2	0
2020	7	0
2021	4	0
2022	4	0
2023	4	0
2024	7	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K984194, 1992–2026Source: 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 MQS? 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 MQS device

#1 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall

Get a 510(k) Report

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
*	K923682	Model M1032A Vuelink Interface Plug-in Module Summary page 1 …ing \| 880.5725 Pump, infusion Gnrl Hospital [ 80 FRN The above device is substantially equivalent to the HP M1032A Vuelink Interface Plug-n Mndule marketed pursuant to K923682. The Hewlett Packard M2378A Devicelink System receives digital data produced by external devices through device specific cables,…	Hewlett-Packard Co.	1992	—

Also cleared against K923682: 6 other devices →

What descends from it? (79)

See all 79

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

Number	Device	Applicant	Decided	Descendants
K992636	HP Carevue 9000 Clinical Information System, Model M2331A	Hewlett-Packard Co.	1999	78

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, K992636 (Hewlett-Packard Co., 1999) has gone furthest, with 78 descendants of its own.
6 other devices also cite its predicate K923682.

How does its category compare?

All MQS devices

MQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQS

1in 2023

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQS

Too few MQS 510(k)s in any year since 2007 to give a median.

Recalls per year · MQS

No recall names MQS since 2007.

Adverse event reports per year · MQS

5in 2013

2007high 68 (2007) · low 0 (2014)2025

MAUDE reports naming product code MQS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	68
2008	0	—	6
2009	0	—	21
2010	0	—	10
2011	0	—	1
2012	0	—	5
2013	1	—	5
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below:

1) IMED 1310 (PC-1) channel IV Pump

2) In-line Diagnostic HR Crit-Line Monitor

3) Newport Wave Ventilator

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/K984194 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984194: HP M2376A Device Link System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984194

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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