510(k) · Cleared

Cleared

A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328

K040229510(k) SpecialCleared Mar 19, 200446-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 Mar 19, 2004 as substantially equivalent to K002115 (A&D Engineering, Inc., 2000) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it.

Decided: Mar 19, 2004
Review: 46 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K002115 (2000). 2 ancestors in all. 22 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
This deviceK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
Descendant · cites it directly · 16 of its ownK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
Descendant · 2 generations on · 6 of its ownK130564 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
Descendant · 3 generations on · 3 of its ownK151281 AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015
Descendant · 2 generations on · 3 of its ownK130563 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
Descendant · 4 generations on · 2 of its ownK193628 AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2004high 3 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 22 · See all

K042967A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512A&D Engineering, Inc. · 2004 · cites it directly16descendants
K130564Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · 2 generations on6descendants
K151281AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015 · 3 generations on3descendants
K130563Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · 2 generations on3descendants
K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002115	A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors	A&D Engineering, Inc.	2000	—
0 (this device)	K040229	A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328	A&D Engineering, Inc.	2004	—
+1	K042967	A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512	A&D Engineering, Inc.	2004	—
+2	K130564	Full Automatic (Nibp) Blood Pressure Monitor	Health & Life Co., Ltd.	2013	—
+3	K151281	AGE Automatic Wrist Blood Pressure Monitor	Dongguan Ageless Health Industrial Co., Ltd.	2015	—
+2	K130563	Full Automatic (Nibp) Blood Pressure Monitor	Health & Life Co., Ltd.	2013	—
+4	K193628	AGE Automatic Wrist Blood Pressure Monitor	Dongguan E-Test Technology Co., Ltd.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	1	0
2009	2	0
2012	2	0
2013	2	0
2014	1	0
2015	3	0
2017	2	0
2018	1	0
2019	1	0
2020	1	0
2021	2	0
2022	1	0
2025	1	0

FIG. 1 — Lineage of K040229, 2000–2025Source: 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? (2)

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
*	K002115	A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors	A&D Engineering, Inc.	2000	—
*	K012472	A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure Monitors Summary page 1 …quivalent to the following three devices: A&D UB-401, FDA 510(k) KO021 15. Issued on July 25, 2000 A&D UA-787, FDA 5 10(k) K012472. Issued on Feb. 15, 2002 6. TECHNOLOGICAL CHARACTERISTECS IJB-328 uses an inflated…	A&D Engineering, Inc.	2002	—

Also cleared against K002115: 1 other device →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K042967	A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512	A&D Engineering, Inc.	2004	16
K083681	Bioland Blood Pressure Monitor	Bioland Technology, Ltd.	2009	1
K070825	LD8 Digital Wrist Blood Pressure Monitor	Little Doctor (Shanghai) Electronic Manufacturing	2007	1
K061935	Sensacare Saw-102 Wrist Digital Blood Pressure Monitor	Sensacare, Ltd.	2006	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 2 ancestors has a recall.
Of its descendants, K042967 (A&D Engineering, Inc., 2004) has gone furthest, with 16 descendants of its own.
1 other device also cites its predicate K002115.

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/K040229 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040229: A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040229

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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