510(k) · Cleared
ClearedTruly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M
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 5 generations to 1991. 2 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 5 generations to K903134 (1991). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 4 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 3 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 2 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 1 generation backK073398 Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp. · 2007
- This deviceK091415 Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK170545 Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK113085 Tryly Automatic Wrist Blood Pressure MonitorTruly Instrument Co., Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −4 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −3 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −2 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −1 | K073398 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100) | Microlife Corp. | 2007 | — |
| 0 (this device) | K091415 | Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200… | Truly Instrument Co., Ltd. | 2009 | — |
| +1 | K170545 | Automatic Wrist Bluetooth Blood Pressure Monitor | Truly Instrument, Ltd. | 2017 | — |
| +1 | K113085 | Tryly Automatic Wrist Blood Pressure Monitor | Truly Instrument Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 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 1! Contraindications · N/A 3. The Perdicate Devices a. Digibio Digital Blood Pressure Monitor, Model Dll, K014141 b. Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW1 00), K073398 4. Device Description… | 2002 |
| * | K073398 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Summary page 1…vices a. Digibio Digital Blood Pressure Monitor, Model Dll, K014141 b. Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW1 00), K073398 4. Device Description Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW… | 2007 |
What descends from it? (2)
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 18 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K170545 (Truly Instrument, Ltd., 2017) has gone furthest, with 0 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 Wrist Blood Pressure Monitor ,Models DW100, 00, MM DW500, DW700,
DW701M, DW702M, DW703 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-wrist,
The devices features includeirregiular pulse thyth~m detection during measurefment,
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/K091415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091415: Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091415
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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