510(k) · Cleared
ClearedTruly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truly Instrument Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 4, 2009 as substantially equivalent to K014141 (Digibio Technology Corp., 2002) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1991. 11 later devices descend from it.
- Decided
- Sep 4, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903134 (1991). 6 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 3 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 2 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 1 generation backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- This deviceK091434 Truly Automatic Arm Blood Pressure…Truly Instrument Co., Ltd. · 2009
- Descendant · cites it directly · 5 of its ownK161846 Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016
- Descendant · 2 generations on · 3 of its ownK192023 Arm Blood Pressure MonitorTruly Instrument Limited · 2019
- Descendant · 3 generations on · 2 of its ownK220113 Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK210671 Digital Blood Pressure Monitor WBP Series, including: WBP101…Weony (Shenzhen) Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK181104 Arm type Blood Pressure Monitor, Digital Blood Pressure…Shenzhen Combei Technology Co., Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016 · cites it directly5descendants
- K192023Arm Blood Pressure MonitorTruly Instrument Limited · 2019 · 2 generations on3descendants
- K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd. · 2022 · 3 generations on2descendants
- K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104…Weony (Shenzhen) Technology Co., Ltd. · 2021 · cites it directly1descendant
- K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −3 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −2 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −1 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| 0 (this device) | K091434 | Truly Automatic Arm Blood Pressure… | Truly Instrument Co., Ltd. | 2009 | — |
| +1 | K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | Truly Instrument Limited | 2016 | — |
| +2 | K192023 | Arm Blood Pressure Monitor | Truly Instrument Limited | 2019 | — |
| +3 | K220113 | Upper Arm Electronic Blood Pressure Monitor (Model… | Shenzhen Finicare Co., Ltd. | 2022 | — |
| +1 | K210671 | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103… | Weony (Shenzhen) Technology Co., Ltd. | 2021 | — |
| +1 | K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic… | Shenzhen Combei Technology Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K014141 | Digibio Digtial Blood Pressure Monitor Model D11Summary page 1…Device Classification: Class II Contraindications: N/A 3. The Predicate Devices a. Digibio Digital Blood Pressure Monitor, Model D11, K014141 b. Microlife Blood Pressure Monitor, Model BP3BTO-AP, K041411 4. Device Description Truly Automatic Arm Blood… | 2002 |
| * | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APSummary page 1…N/A 3. The Predicate Devices a. Digibio Digital Blood Pressure Monitor, Model D11, K014141 b. Microlife Blood Pressure Monitor, Model BP3BTO-AP, K041411 4. Device Description Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB… | 2004 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | 2016 | 5 |
| K210671 | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104… | 2021 | 1 |
| K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style | 2018 | 1 |
| K113083 | Truly Automatic Arm Blood Pressure Monitor | 2012 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K161846 (Truly Instrument Limited, 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K014141.
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. 2009, 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?
Truly Automatic Arm Blood Pressure Monitor ,Models DB21, DB22, DB23, DB31, DB32, DB61 M, DB62M, DB63M, DB71M are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091434
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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