510(k) · Cleared

Cleared

Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX

K983575510(k) TraditionalCleared May 13, 1999212-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

Datascope Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on May 13, 1999 after a 212-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 122 later devices descend from it.

Decided: May 13, 1999
Review: 212 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

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

This deviceK983575 Accutorr Plus Non Invasive Blood Pressure Monitor, Model #…Datascope Corp. · 1999
Descendant · cites it directly · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
Descendant · 2 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
Descendant · 3 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
Descendant · 2 generations on · 75 of its ownK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
Descendant · 4 generations on · 71 of its ownK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled

Showing 5 of 122 descendants. See all descendants

Descendants cleared per year

2000high 11 (2009) · low 0 (2001)2026

Most influential descendants

Showing 5 of 122 · See all

K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · cites it directly119descendants
K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 2 generations on88descendants
K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 3 generations on87descendants
K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · 2 generations on75descendants
K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 4 generations on71descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K983575	Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX	Datascope Corp.	1999	—
+1	K993531	Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX	Datascope Corp.	2000	1
+2	K032733	PM-8000 Patient Monitor, Model 8000	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2004	—
+3	K043348	Modification to PM-8000 Patient Monitor	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2005	—
+2	K020550	Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX	Datascope Corp.	2002	1
+4	K053234	PM-9000 Express Patient Monitor	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2006	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2006	6	0
2007	4	0
2008	5	0
2009	11	0
2010	10	0
2011	5	0
2012	5	0
2013	7	0
2014	6	0
2015	7	0
2016	6	0
2017	7	0
2018	8	0
2019	5	0
2020	1	0
2021	5	0
2022	6	0
2023	5	0
2024	4	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K983575, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (122)

See all 122

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

Number	Device	Applicant	Decided	Descendants
K993531	Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX	Datascope Corp.	2000	119
K102004	Endeavour Monitoring System	Mindray DS USA, Inc.	2010	3
K091068	Accutorr V Monitor, Model 0998-00-2000	Datascope Corp., Patient Monitoring Division	2009	2

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, K993531 (Datascope Corp., 2000) has gone furthest, with 119 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	—

What is it indicated for?

The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:

Blood Oxygenation (SpO₂) measurement

Temperature measurement

Non Invasive Blood Pressure (NIBP) measurement

Heart Rate derived from selected source (SpO₂, NIBP)

The target populations are adult, pediatric and neonate populations. The monitor is intended for use within the health care facility setting.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983575 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983575: Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983575

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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