510(k) · Cleared
ClearedKorotkoff sound blood pressure monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Hanvon Health Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 21, 2026 as substantially equivalent to K251120 (Microlife Corporation, 2025) after a 130-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Apr 21, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K903134 (1991). 26 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 8 generations between
- 3 generations backK172498 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2017
- 2 generations backK230075 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2023
- 1 generation backK251120 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Corporation · 2025
- This deviceK253982 Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 11 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 10 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 9 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 8 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 7 generations backK073198 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
- 6 generations backK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- 5 generations backK151869 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
- 4 generations backK153077 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016
- 3 generations backK172498 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2017
- 2 generations backK230075 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2023
- 1 generation backK251120 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Corporation · 2025
- This deviceK253982 Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −11 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −10 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −9 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −8 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −7 | K073198 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −6 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −5 | K151869 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | 2015 | — |
| −4 | K153077 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2016 | — |
| −3 | K172498 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y | Microlife Intellectual Property GmbH | 2017 | — |
| −2 | K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Microlife Intellectual Property GmbH | 2023 | — |
| −1 | K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP… | Microlife Corporation | 2025 | — |
| 0 (this device) | K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Summary page 5…stem System, Measurement, Blood-Pressure, Non-Invasive 870.1130 DXN, DXN Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K251120 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) DXN Device Description Summary 21… | 2025 |
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 35 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- None of the 26 ancestors has a recall.
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. 2026, 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?
The device is a digital monitor intended for use in measuring the systolic pressure and diastolic pressure, as well as the pulse rate of adults and adolescents via a non-invasive auscultatory method in medical facilities or at home, with an inflatable cuff wrapped around the upper arm for arm circumferences ranging from 22 to 42 cm. The measurement ranges of the device are systolic pressure 40 ~ 280 mmHg (supported by automatic mode for 40 to 210 mmHg…
Read the full statement (129 words)
The device is a digital monitor intended for use in measuring the systolic pressure and diastolic pressure, as well as the pulse rate of adults and adolescents via a non-invasive auscultatory method in medical facilities or at home, with an inflatable cuff wrapped around the upper arm for arm circumferences ranging from 22 to 42 cm. The measurement ranges of the device are systolic pressure 40 ~ 280 mmHg (supported by automatic mode for 40 to 210 mmHg and manual mode for 210 to 280 mmHg), diastolic pressure 20 ~ 220 mmHg, and pulse rate 40 ~ 240 beats/min.
The device can detect Irregular Heart Beat (IHB), Atrial Fibrillation, Tachycardia, and evaluate Blood Pressure Variability (BPV) and Time in Target Range (TTR) according to the measured blood pressure values.
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/K253982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253982: Korotkoff sound 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/K253982
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026