510(k) · Cleared

Cleared

HP Model M1008B, Noninvasive Blood Pressure Module

K903771510(k) TraditionalCleared Feb 19, 1991183-day reviewClass II21 CFR 870.1130

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

Hewlett-Packard Co. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Feb 19, 1991 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 255 later devices descend from it.

Decided: Feb 19, 1991
Review: 183 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

255 later devices descend from it, 3 citing it directly.

This deviceK903771 HP Model M1008B, Noninvasive Blood Pressure ModuleHewlett-Packard Co. · 1991
Descendant · cites it directly · 253 of its ownK014159 Phillips M1175A/76A/77A Component Monitoring System; Phillips…Philips Medical Systems, Inc. · 2002
Descendant · 2 generations on · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
Descendant · 2 generations on · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
Descendant · 2 generations on · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 255 descendants. See all descendants

Descendants cleared per year

1996high 21 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 255 · See all

K014159Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient MonitorPhilips Medical Systems, Inc. · 2002 · cites it directly253descendants
K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · 2 generations on252descendants
K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · 2 generations on251descendants
K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on250descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K903771	HP Model M1008B, Noninvasive Blood Pressure Module	Hewlett-Packard Co.	1991	—
+1	K014159	Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient…	Philips Medical Systems, Inc.	2002	—
+2	K041235	Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	2004	—
+2	K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…	Philips Medizin Systeme Boblingen GmbH	2004	—
+2	K050141	The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…	Philips Medizin Systeme Boeblingen GmbH	2005	—
+2	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
1996	1	0
2002	1	0
2004	2	0
2005	6	0
2006	10	0
2007	4	0
2008	5	0
2009	5	0
2010	8	0
2011	10	0
2012	9	0
2013	12	0
2014	11	0
2015	7	0
2016	12	0
2017	12	0
2018	15	0
2019	10	0
2020	10	0
2021	13	0
2022	19	0
2023	21	0
2024	18	0
2025	21	0
2026	13	0

FIG. 1 — Lineage of K903771, 1991–2026Source: 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.

Planning a device in DXN? 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 DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (255)

See all 255

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

Number	Device	Applicant	Decided	Descendants
K014159	Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient Monitor	Philips Medical Systems, Inc.	2002	253
K101600	Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	37
K961401	HP Cathstation - Model M1264B	Hewlett-Packard Co.	1996	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?

Of its descendants, K014159 (Philips Medical Systems, Inc., 2002) has gone furthest, with 253 descendants of its own.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, 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	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

https://510kreport.com/device/K903771 · printed Nov 4, 2026

Cite this page

510(k) Report. “K903771: HP Model M1008B, Noninvasive Blood Pressure Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903771

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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