510(k) · Cleared

Cleared

Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506

K031479510(k) SpecialCleared Jun 6, 200329-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

Datex-Ohmeda, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jun 6, 2003 as substantially equivalent to K855127 (Spacelabs, Inc., 1986) after a 29-day review. Its family tree reaches back 1 generation to 1986. 21 later devices descend from it.

Decided: Jun 6, 2003
Review: 29 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K855127 (1986). 21 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
This deviceK031479 Ambulatory Blood Pressure (Abp) 92506 Report Management System…Datex-Ohmeda, Inc. · 2003
Descendant · cites it directly · 19 of its ownK060315 Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006
Descendant · 2 generations on · 13 of its ownK173028 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT…Healthstats International Pte., Ltd. · 2018
Descendant · 3 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
Descendant · 4 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
Descendant · 2 generations on · 4 of its ownK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2004high 4 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 21 · See all

K060315Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006 · cites it directly19descendants
K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareHealthstats International Pte., Ltd. · 2018 · 2 generations on13descendants
K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 3 generations on12descendants
K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 4 generations on5descendants
K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K855127	Ambulatory Blood Pressure Monitor Spacelabs #90202	Spacelabs, Inc.	1986	—
0 (this device)	K031479	Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model…	Datex-Ohmeda, Inc.	2003	—
+1	K060315	Healthstats Bpro Ambulatory Blood Pressure Monitoring System	Healthstats International Pte., Ltd.	2006	—
+2	K173028	BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software	Healthstats International Pte., Ltd.	2018	—
+3	K190792	BB-613WP	Biobeat Technologies, Ltd.	2019	—
+4	K212153	Biobeat Platform, BB-613WP Patch	Biobeat Technologies, Ltd.	2022	—
+2	K072593	A-Plus Arterial Pulse Waveform Analysis System and PC Software	Healthstats International Pte., Ltd.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	1	0
2010	1	0
2012	1	0
2014	2	0
2018	1	0
2019	1	0
2022	2	0
2023	2	0
2024	1	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K031479, 1986–2026Source: 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 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? (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
*	K855127	Ambulatory Blood Pressure Monitor Spacelabs #90202 Summary page 1 …anagement System (RMS) is substantially equivalent to the following currently marketed device(s): Spacelabs Medical Ambulatory Blood Pressure Monitor K855127 (includes 90219 RMS) Spacelabs Medical Ambulatory Blood Pressure Monitor K855127 (Letter to File) (includes…	Spacelabs, Inc.	1986	—

Also cleared against K855127: 5 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K060315	Healthstats Bpro Ambulatory Blood Pressure Monitoring System	Healthstats International Pte., Ltd.	2006	19
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?

Its one ancestor has no recall.
Of its descendants, K060315 (Healthstats International Pte., Ltd., 2006) has gone furthest, with 19 descendants of its own.
5 other devices also cite its predicate K855127.

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 ABP 92506 RMS is used to provide data to qualified medical personnel for the purpose of assessing the patient’s cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period.

The data is intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only.

It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician.

Patient diagnosis is not to be performed solely based on the results of this device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031479 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031479: Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031479

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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