510(k) · Cleared
ClearedAutomatic Arm Bluetooth Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truly Instrument Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 24, 2016 as substantially equivalent to K121025 (Ya Horng Electronic Co., Ltd., 2012) and 1 other predicate after a 111-day review. Its family tree reaches back 6 generations to 2000. 5 later devices descend from it.
- Decided
- Oct 24, 2016
- Review
- 111 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001182 (2000). 15 ancestors in all, the oldest K903134 (1991). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
- 5 generations backK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
- 4 generations backK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
- 3 generations backK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
- 2 generations backK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
- 1 generation backK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012
- This deviceK161846 Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016
- Descendant · cites it directly · 3 of its ownK192023 Arm Blood Pressure MonitorTruly Instrument Limited · 2019
- Descendant · 2 generations on · 2 of its ownK220113 Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK252769 Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123…Shenzhen Finicare Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK242721 Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106…Shenzhen Finicare Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK170545 Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument, Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K192023Arm Blood Pressure MonitorTruly Instrument Limited · 2019 · cites it directly3descendants
- K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd. · 2022 · 2 generations on2descendants
- K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126…Shenzhen Finicare Co., Ltd. · 2025 · 3 generations on0descendants
- K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120…Shenzhen Finicare Co., Ltd. · 2024 · 3 generations on0descendants
- K170545Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001182 | Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 | Microlife Corp. | 2000 | — |
| −5 | K012796 | Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000 | Amluck, Inc. | 2002 | — |
| −4 | K051862 | PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R… | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −3 | K072860 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −2 | K090058 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U… | Ya Horng Electronic Co., Ltd. | 2009 | — |
| −1 | K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth… | Ya Horng Electronic Co., Ltd. | 2012 | — |
| 0 (this device) | K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | Truly Instrument Limited | 2016 | — |
| +1 | K192023 | Arm Blood Pressure Monitor | Truly Instrument Limited | 2019 | — |
| +2 | K220113 | Upper Arm Electronic Blood Pressure Monitor (Model… | Shenzhen Finicare Co., Ltd. | 2022 | — |
| +3 | K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125… | Shenzhen Finicare Co., Ltd. | 2025 | — |
| +3 | K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113… | Shenzhen Finicare Co., Ltd. | 2024 | — |
| +1 | K170545 | Automatic Wrist Bluetooth Blood Pressure Monitor | Truly Instrument, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K121025 | YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionSummary page 4…cate Devices 3-1. YA HORNG Electronic Co., Ltd Upper Arm Blood Pressure Monitor. Model BP-700NW and Bluetooth Transmission BP-700W. K Number : K121025 3-2. TRULY Instrument Limited. Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62M. K Number :K0… | 2012 |
| * | K091434 | Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M…Summary page 4…BP-700W. K Number : K121025 3-2. TRULY Instrument Limited. Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62M. K Number :K091434 4. Device Description Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are designed… | 2009 |
What descends from it? (5)
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 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K192023 (Truly Instrument Limited, 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K121025.
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. 2016, 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 Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 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 will display a alert signal with the reading when irregular heartbeat is detected.
The devices’ feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161846: Automatic Arm Bluetooth 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/K161846
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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