510(k) · Cleared
ClearedFull Automatic (Nibp) Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 19, 2013 as substantially equivalent to K093824 (Health & Life Co., Ltd., 2010) and 1 other predicate after a 107-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.
- Decided
- Jun 19, 2013
- Review
- 107 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002115 (2000). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002115 A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure…A&D Engineering, Inc. · 2000
- 2 generations backK040229 A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328A&D Engineering, Inc. · 2004
- 1 generation backK042967 A&D Medical Lifesource Digital Blood Pressure Monitors, Models…A&D Engineering, Inc. · 2004
- This deviceK130564 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK151281 AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK193628 AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK213503 Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK181154 Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK250161 Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor…Shenzhen AOJ Medical Technology Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151281AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd. · 2015 · cites it directly3descendants
- K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020 · 2 generations on2descendants
- K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2019 · cites it directly1descendant
- K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…Shenzhen AOJ Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002115 | A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2000 | — |
| −2 | 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 | — |
| 0 (this device) | K130564 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +1 | K151281 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan Ageless Health Industrial Co., Ltd. | 2015 | — |
| +2 | K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020 | — |
| +3 | K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +1 | K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital… | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2019 | — |
| +4 | K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor… | Shenzhen AOJ Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K093824 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BTSummary page 1…roduct Code: DXN Panel: 74 Cardiovascular Information for the 510(k) Cleared Device (Predicate Device): A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT, K093824 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967 Device Description: HLI158LA uses the oscillometric method to auto… | 2010 |
| * | K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512Summary page 1…he 510(k) Cleared Device (Predicate Device): A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT, K093824 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967 Device Description: HLI158LA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as we… | 2004 |
What descends from it? (6)
2 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 13 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K151281 (Dongguan Ageless Health Industrial Co., Ltd., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K093824.
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. 2013, this device’s year, is highlighted.
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?
HLIS8LA automatically measures human's Systolic, Diastolic blood pressufe and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 ¢cm to 19.5 cm) and for home use. When the device detects the appearance of…
Read the full statement (137 words)
HLIS8LA automatically measures human's Systolic, Diastolic blood pressufe and heart
rate by using the oscillometric method. All values can be read out in one LCD panel.
Measurement position is at human being's wrist. The intended use of this
over-the-counter device is for use by people over the age of 18 with wrist circumference
ranging from approx. 5.3 to 7.7 inches(13.5 ¢cm to 19.5 cm) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an
indicated symbol will appear with measuring readings. And this device can let the
memory data be transferred to the connected personal computer (PC) via USB cable.
Besides, Risk Category Indicator (Six Levels) feature will judge blood ‘pressure results
into six levels based on WHO (World Health Organization) classification with
corresponding bar segment on the edge of screen.
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/K130564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130564: Full Automatic (Nibp) Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130564
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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