510(k) · Cleared
ClearedFull Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
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 Sep 8, 2021 as substantially equivalent to K180240 (Health & Life Co., Ltd., 2018) after a 145-day review. Its family tree reaches back 11 generations to 1985.
- Decided
- Sep 8, 2021
- Review
- 145 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K850316 (1985). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 7 generations between
- 3 generations backK142968 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014
- 2 generations backK153214 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- 1 generation backK180240 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2018
- This deviceK211127 Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 10 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 9 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 8 generations backK071384 Modification to: Digital Blood Pressure Monitor, Model 1901Nihon Seimitsu Sokki Co., Ltd. · 2007
- 7 generations backK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- 6 generations backK092161 Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009
- 5 generations backK093831 Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010
- 4 generations backK131121 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- 3 generations backK142968 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014
- 2 generations backK153214 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- 1 generation backK180240 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2018
- This deviceK211127 Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −10 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −9 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −8 | K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007 | — |
| −7 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −6 | K092161 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF | Health & Life Co., Ltd. | 2009 | — |
| −5 | K093831 | Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT | Health & Life Co., Ltd. | 2010 | — |
| −4 | K131121 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| −3 | K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2014 | — |
| −2 | K153214 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| −1 | K180240 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2018 | — |
| 0 (this device) | K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | Health & Life Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K180240 | Full Automatic (NIBP) Blood Pressure MonitorSummary page 4…Product Code: DXN 3. Information for the 510(k) Cleared Device (Predicate Device): A. Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858DK (K180240) 7-1… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 27 ancestors has a recall of any class.
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. 2021, 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?
This device 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 the LCD panel. Measurement position is at human being’s upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.…
Read the full statement (213 words)
This device 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 the LCD panel. Measurement position is at human being’s upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.
HL858DM features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.
HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.
Besides, the device features a built-in "Bluetooth Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211127: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211127
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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