510(k) · Cleared

Cleared

Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553)

K941167510(k) TraditionalCleared Nov 14, 1994245-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

Spacelabs Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Nov 14, 1994 after a 245-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 152 later devices descend from it.

Decided: Nov 14, 1994
Review: 245 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

152 later devices descend from it, 2 citing it directly.

This deviceK941167 Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553)Spacelabs Medical, Inc. · 1994
Descendant · cites it directly · 150 of its ownK952912 Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997
Descendant · 2 generations on · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
Descendant · 3 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
Descendant · 4 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
Descendant · 5 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005

Showing 5 of 152 descendants. See all descendants

Descendants cleared per year

1997high 10 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 152 · See all

K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997 · cites it directly150descendants
K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · 2 generations on149descendants
K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · 3 generations on119descendants
K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 4 generations on88descendants
K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 5 generations on87descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K941167	Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553)	Spacelabs Medical, Inc.	1994	—
+1	K952912	Spacelabs Medical Integrated Multi-Parameter Module	Spacelabs Medical, Inc.	1997	—
+2	K972502	Spacelabs Medical Integrated Multiparameter Module 90496	Spacelabs Medical, Inc.	1998	3
+3	K993531	Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX	Datascope Corp.	2000	1
+4	K032733	PM-8000 Patient Monitor, Model 8000	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2004	—
+5	K043348	Modification to PM-8000 Patient Monitor	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2002	1	0
2003	1	0
2004	3	0
2005	3	0
2006	6	0
2007	4	0
2008	7	0
2009	10	0
2010	10	0
2011	5	0
2012	6	0
2013	7	0
2014	9	0
2015	10	0
2016	7	0
2017	9	0
2018	8	0
2019	7	0
2020	2	0
2021	5	0
2022	7	0
2023	7	0
2024	6	0
2025	3	0
2026	5	0

FIG. 1 — Lineage of K941167, 1994–2026Source: 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

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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? (152)

See all 152

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

Number	Device	Applicant	Decided	Descendants
K952912	Spacelabs Medical Integrated Multi-Parameter Module	Spacelabs Medical, Inc.	1997	150
K041169	Piesometer, Model MK-1	Canamet Canadian Natl Medical Technologies, Inc.	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?

Of its descendants, K952912 (Spacelabs Medical, Inc., 1997) has gone furthest, with 150 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/K941167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941167: Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941167

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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