510(k) · Cleared

Cleared

A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors

K032499510(k) SpecialCleared Oct 30, 200378-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

A&D Engineering, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Oct 30, 2003 as substantially equivalent to K871718 (A&D Engineering, Inc., 1987) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1987. 8 later devices descend from it.

Decided: Oct 30, 2003
Review: 78 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K871718 (1987). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
This deviceK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
Descendant · cites it directly · 4 of its ownK061456 A & D Medical UM-101 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2006
Descendant · 2 generations on · 1 of its ownK173191 A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019
Descendant · cites it directly · 1 of its ownK083681 Bioland Blood Pressure MonitorBioland Technology, Ltd. · 2009
Descendant · 3 generations on · 0 of its ownK212168 A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022
Descendant · 2 generations on · 0 of its ownK200560 InBodyInbody Co., Ltd. · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006high 1 (2006) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all

K061456A & D Medical UM-101 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2006 · cites it directly4descendants
K173191A&D Medical Blood Pressure MonitorsA&D Company, Ltd. · 2019 · 2 generations on1descendant
K083681Bioland Blood Pressure MonitorBioland Technology, Ltd. · 2009 · cites it directly1descendant
K212168A&D Medical UM-212BLE Blood Pressure MonitorA&D Company, Ltd. · 2022 · 3 generations on0descendants
K200560InBodyInbody Co., Ltd. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871718	Modified Model UA-711 Digital Sphygmonometer	A&D Engineering, Inc.	1987	—
0 (this device)	K032499	A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors	A&D Engineering, Inc.	2003	—
+1	K061456	A & D Medical UM-101 Digital Blood Pressure Monitor	A&D Engineering, Inc.	2006	—
+2	K173191	A&D Medical Blood Pressure Monitors	A&D Company, Ltd.	2019	—
+1	K083681	Bioland Blood Pressure Monitor	Bioland Technology, Ltd.	2009	—
+3	K212168	A&D Medical UM-212BLE Blood Pressure Monitor	A&D Company, Ltd.	2022	—
+2	K200560	InBody	Inbody Co., Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2009	1	0
2010	1	0
2012	1	0
2019	1	0
2021	1	0
2022	1	0

FIG. 1 — Lineage of K032499, 1987–2022Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K871718	Modified Model UA-711 Digital Sphygmonometer Summary page 1 …5. PREDICATE DEVCIE It is substantially equivalent to the following three devices: A&D UA-7 11, FDA 5 1O(k) K87 1718. Issued on June 24, 1987 A&D UA-767PC, FDA 5 1O(k) K98248 1. Issued on Jan. 13, 1999…	A&D Engineering, Inc.	1987	—
*	K982481	A&D Medical UA-767PC Digital Blood Pressure Monitor Summary page 1 …ivalent to the following three devices: A&D UA-7 11, FDA 5 1O(k) K87 1718. Issued on June 24, 1987 A&D UA-767PC, FDA 5 1O(k) K98248 1. Issued on Jan. 13, 1999 A&D UA-787, FDA 5 1O(k) KO 12472. Issued on Feb. 15,2002 Attachment D - 510(k)…	A&D Engineering, Inc.	1998	—
*	K012472	A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure Monitors	A&D Engineering, Inc.	2002	—

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K061456	A & D Medical UM-101 Digital Blood Pressure Monitor	A&D Engineering, Inc.	2006	4
K083681	Bioland Blood Pressure Monitor	Bioland Technology, Ltd.	2009	1
K111141	Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure Monitor	Wenzhou Bokang Instruments Co., Ltd.	2012	0
K071075	Terumo Digital Blood Pressure Monitor ES-H55A	Terumo Corp.	2007	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?

None of the 3 ancestors has a recall.
Of its descendants, K061456 (A&D Engineering, Inc., 2006) has gone furthest, with 4 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?

Measure blood pressure (systolic and diastolic) and pulse rate.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032499 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032499: A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032499

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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