510(k) Report

510(k) · Cleared

Cleared

A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors

K002115510(k) TraditionalCleared Jul 25, 200012-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 Jul 25, 2000 after a 12-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 23 later devices descend from it.

Decided
Jul 25, 2000
Review
12 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

23 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2009: 2 descendants cleared2013: 2 descendants cleared2012: 2 descendants cleared2014: 1 descendant cleared2017: 2 descendants cleared2015: 3 descendants cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 2 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
  2. Descendant · cites it directly · 22 of its ownK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
  3. Descendant · cites it directly · 16 of its ownK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
  4. Descendant · 2 generations on · 6 of its ownK130564 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
  5. Descendant · 3 generations on · 3 of its ownK151281 AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015
  6. Descendant · 2 generations on · 3 of its ownK130563 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2004: 22006: 12007: 12009: 22012: 22013: 22014: 12015: 32017: 22018: 12019: 12020: 12021: 22022: 12025: 1
2004high 3 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 23 · See all
  • K040229A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004 · cites it directly22descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002115A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure MonitorsA&D Engineering, Inc.2000—
+1K040229A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc.2004—
+1K042967A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512A&D Engineering, Inc.2004—
+2K130564Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd.2013—
+3K151281AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd.2015—
+2K130563Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200610
200710
200920
201220
201320
201410
201530
201720
201810
201910
202010
202120
202210
202510
FIG. 1 — Lineage of K002115, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K040229A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc.200422
K042967A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512A&D Engineering, Inc.200416

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, K040229 (A&D Engineering, Inc., 2004) has gone furthest, with 22 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

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
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

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

More from A&D Engineering, Inc.

34 FDA decisions under this applicant name. See the company

  • K082734A&D Medical UA-851THW Digital Blood Pressure MonitorA&D Engineering, Inc. · 2008
  • K062027A&D Medical UA-789 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2007
  • K061456A & D Medical UM-101 Digital Blood Pressure MonitorA&D Engineering, Inc. · 2006
  • K043217A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 20051 recall
  • K042967A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512A&D Engineering, Inc. · 2004

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K002115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002115: A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002115

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026