510(k) · Cleared

Cleared

Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control

K964235510(k) TraditionalCleared Mar 2, 1999860-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

Industrielle Entwicklung Medizintechnik Und Vertri · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 2, 1999 as substantially equivalent to K855127 (Spacelabs, Inc., 1986) after an 860-day review. Its family tree reaches back 1 generation to 1986. 14 later devices descend from it.

Decided: Mar 2, 1999
Review: 860 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K855127 (1986). 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
This deviceK964235 Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlIndustrielle Entwicklung Medizintechnik Und Vertri · 1999
Descendant · cites it directly · 9 of its ownK072446 Mobil-O-Graph NG 24 H Abp-ControlI.E.M. GmbH · 2007
Descendant · 2 generations on · 8 of its ownK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
Descendant · 3 generations on · 5 of its ownK140928 ABPM7100I.E.M. GmbH · 2014
Descendant · 4 generations on · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
Descendant · cites it directly · 2 of its ownK012647 Tonoport VPar Medizintechnik GmbH · 2001

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2001high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 14 · See all

K072446Mobil-O-Graph NG 24 H Abp-ControlI.E.M. GmbH · 2007 · cites it directly9descendants
K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011 · 2 generations on8descendants
K140928ABPM7100I.E.M. GmbH · 2014 · 3 generations on5descendants
K151520Oscar 2Suntech Medical, Inc. · 2016 · 4 generations on3descendants
K012647Tonoport VPar Medizintechnik GmbH · 2001 · cites it directly2descendants

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)	K964235	Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control	Industrielle Entwicklung Medizintechnik Und Vertri	1999	—
+1	K072446	Mobil-O-Graph NG 24 H Abp-Control	I.E.M. GmbH	2007	—
+2	K110603	Hypertension Management Software Claient Server (HMS-CS)	I.E.M. GmbH	2011	—
+3	K140928	ABPM7100	I.E.M. GmbH	2014	—
+4	K151520	Oscar 2	Suntech Medical, Inc.	2016	2
+1	K012647	Tonoport V	Par Medizintechnik GmbH	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2007	1	0
2011	1	0
2012	1	0
2014	2	0
2016	2	0
2017	1	0
2021	1	0
2026	2	0

FIG. 1 — Lineage of K964235, 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 …the Ultralite Ambulatory Blood Pressure Monitor, Model SL 90202, manufactured by Space Labs, Incorporated of Redwood, Washington (determined substantially equivalent via K 855127). A determination of substantial equivalence is based upon: Both the ABPM Mobil-o- Graph tm Blood Pressure Monitor, Model ABP Co…	Spacelabs, Inc.	1986	—

Also cleared against K855127: 5 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K072446	Mobil-O-Graph NG 24 H Abp-Control	I.E.M. GmbH	2007	9
K012647	Tonoport V	Par Medizintechnik GmbH	2001	2
K021517	Abp for Windows	Rozinn Electronics, Inc.	2002	0
K021029	ABP-2000 G-3	Biotrac, Inc.	2002	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, K072446 (I.E.M. GmbH, 2007) has gone furthest, with 9 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?

This portable device, the ABPM Maobil-o- Graph '™ Blood Pressure Monitor manufactured by LE.M. Gmbl! is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate) systolic and diastolic data of a individual adult-patient (in the patient’s environment) for a scssion which may last 24 to 48 hours.

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/K964235 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964235: Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964235

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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