510(k) · Cleared
ClearedA&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A&D Engineering, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 3, 2004 as substantially equivalent to K002115 (A&D Engineering, Inc., 2000) and 1 other predicate after a 36-day review. Its family tree reaches back 2 generations to 2000. 16 later devices descend from it.
- Decided
- Dec 3, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002115 (2000). 3 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
- 1 generation backK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
- This deviceK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK130564 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · 2 generations on · 3 of its ownK151281 AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK130563 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK193628 AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK121355 Wrist-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K130564Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · cites it directly6descendants
- K151281AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015 · 2 generations on3descendants
- K130563Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · cites it directly3descendants
- K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020 · 3 generations on2descendants
- K121355Wrist-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd. · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2000 | — |
| −1 | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328 | A&D Engineering, Inc. | 2004 | — |
| 0 (this device) | K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512 | A&D Engineering, Inc. | 2004 | — |
| +1 | K130564 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +2 | K151281 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan Ageless Health Industrial Co., Ltd. | 2015 | — |
| +1 | K130563 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +3 | K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020 | — |
| +1 | K121355 | Wrist-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 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 |
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
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 | Decided |
|---|---|---|---|
| * | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure MonitorsSummary page 1…PREDICATE DEVCIE It is substantially equivalent to the following three devices: A&DUIB-401, FDA 510(k) K0021 15. Issued on July 25, 2000 A&D UA-328, FDA 510(k) K040229. Issued on June 30,2004 6.… | 2000 |
| * | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328Summary page 1…nt to the following three devices: A&DUIB-401, FDA 510(k) K0021 15. Issued on July 25, 2000 A&D UA-328, FDA 510(k) K040229. Issued on June 30,2004 6. TECHNOLOGICAL CHARACTERISTECS UB-5i11 & UB-512 u… | 2004 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130564 (Health & Life Co., Ltd., 2013) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K002115.
How does its category compare?
All DXN devicesDXN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 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/K042967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042967: A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042967
Report an extraction error
Are you the manufacturer?
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