510(k) · Cleared
ClearedBlood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Diaier Electronic Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 21, 2009 as substantially equivalent to K070473 (Zen Strong Medical Technology Co., Ltd., 2007) after a 117-day review. Its family tree reaches back 5 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 21, 2009
- Review
- 117 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903134 (1991). 7 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 backK070473 Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd. · 2007
- This deviceK091553 Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300…Ningbo Diaier Electronic Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK123839 WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK093739 Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd. · 2010
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 | K070473 | Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX | Zen Strong Medical Technology Co., Ltd. | 2007 | — |
| 0 (this device) | K091553 | Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper… | Ningbo Diaier Electronic Co., Ltd. | 2009 | — |
| +1 | K123839 | WA Series: WA100; WA200; WD100; WE100, WF100; WB200 | Ningbo Diaier Electronic Co., Ltd. | 2013 | — |
| +1 | K093739 | Blood Pressure Monitor/ Models | Ningbo Diaier Electronic Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K070473 | Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXSummary page 2…rt for home care use( without the involvement of professional physician). 6. Comparison to the 510(k)Cleared Device (Predicate Device): 1> Zen Strong model ZSBP-001 (K070473) for wrist model model WA400. 2> Zen Strong model ZSBP-1 01 (K070473) for upper arm model AA300. 7. Discussion of Non-Clinica… | 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 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K123839 (Ningbo Diaier Electronic Co., Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070473.
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?
WA400 blood pressure monitor measures automatically human being~ systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician) AA300 blood pressure monitor measures automatically human being systolic, diastolic blood…
Read the full statement (131 words)
WA400 blood pressure monitor measures automatically human being~ systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)
AA300 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home car6 use( without the involvement of professional physician).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091553: Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091553
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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