510(k) · Cleared
ClearedArm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joytech Healthcare Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 13, 2026 as substantially equivalent to K232621 (Guangdong Transtek Medical Electronics Co., Ltd., 2023) and 1 other predicate after a 316-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Aug 13, 2026
- Review
- 316 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K903134 (1991). 41 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 7 generations between
- 3 generations backK153077 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016
- 2 generations backK222979 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2023
- 1 generation backK232621 Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023
- This deviceK253425 Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 10 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 9 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 8 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 7 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 6 generations backK073198 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
- 5 generations backK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- 4 generations backK151869 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
- 3 generations backK153077 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016
- 2 generations backK222979 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2023
- 1 generation backK232621 Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd. · 2023
- This deviceK253425 Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −10 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −9 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −8 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −7 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −6 | K073198 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −5 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −4 | K151869 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | 2015 | — |
| −3 | K153077 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2016 | — |
| −2 | K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | Microlife Intellectual Property GmbH | 2023 | — |
| −1 | K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023 | — |
| 0 (this device) | K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor… | Joytech Healthcare 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 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K232621 | Blood pressure monitorSummary page 6…d Pressure Monitors are substantially equivalent to the following predicate devices: 510(k) number Predicate device model Product code Manufacturer K232621 TMB-2092-G DXN Guangdong Transtek Medical… | 2023 |
| * | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Summary page 6…TMB-2092-G DXN Guangdong Transtek Medical Electronics Co., Ltd. K230566 DBP-61A0, DBP- DXN JOYTECH Healthcare Co., Ltd. 62A1B, DBP-61A2,… | 2023 |
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 2.5 years on median.
- None of the 41 ancestors has a recall.
- 2 other devices also cite its predicate K232621.
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 Arm-type Fully Automatic Digital Blood Pressure monitors are intended to measure blood pressure(systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 36 cm or 22cm to42cm or 32cm to 48cm.
The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.
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/K253425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253425: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253425
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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