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 18, 2013 as substantially equivalent to K093831 (Health & Life Co., Ltd., 2010) and 1 other predicate after a 106-day review. Its family tree reaches back 7 generations to 1985. 3 later devices descend from it.
- Decided
- Jun 18, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K850316 (1985). 18 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 6 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 5 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 4 generations backK071384 Modification to: Digital Blood Pressure Monitor, Model 1901Nihon Seimitsu Sokki Co., Ltd. · 2007
- 3 generations backK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- 2 generations backK092161 Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009
- 1 generation backK093831 Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010
- This deviceK130563 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK180240 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK211127 Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK150311 Full Automatic (NIBP)Blood Pressure MonitorHealth & Life Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K180240Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2018 · cites it directly1descendant
- K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd. · 2021 · 2 generations on0descendants
- K150311Full Automatic (NIBP)Blood Pressure MonitorHealth & Life Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −6 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −5 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −4 | K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007 | — |
| −3 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −2 | K092161 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF | Health & Life Co., Ltd. | 2009 | — |
| −1 | K093831 | Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT | Health & Life Co., Ltd. | 2010 | — |
| 0 (this device) | K130563 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +1 | K180240 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2018 | — |
| +2 | K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | Health & Life Co., Ltd. | 2021 | — |
| +1 | K150311 | Full Automatic (NIBP)Blood Pressure Monitor | Health & Life Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K093831 | Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTSummary page 1…el: 74 Cardiovascular Product Code: DXN 3. Information for the 510(k) Cleared Device (Predicate Device): A. Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT, K093831 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967 4. Device Description: HL858GA uses the oscillometric method to aut… | 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 HL868RT, K093831 B. A&D Digital Blood Pressure Monitor, Model UB-512, K042967 4. Device Description: HL858GA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as w… | 2004 |
What descends from it? (3)
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 28 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K180240 (Health & Life Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093831.
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?
HL858GA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s arm. All values can be read out in one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use. When the device detects the appearance of irregular heartbeats…
Read the full statement (139 words)
HL858GA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s arm. All values can be read out in one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 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/K130563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130563: Full Automatic (Nibp) Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130563
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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