510(k) · Cleared
ClearedBlood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zen Strong Medical Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 23, 2007 as substantially equivalent to K050249 (Health & Life Co., Ltd., 2005) and 1 other predicate after a 92-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- May 23, 2007
- Review
- 92 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. 4 later devices descend from it, 2 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 deviceK070473 Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK091553 Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300…Ningbo Diaier Electronic Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK123839 WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK093739 Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK090027 Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and…Zen Strong Medical Technology Co., Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K091553Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm TypeNingbo Diaier Electronic Co., Ltd. · 2009 · cites it directly2descendants
- K123839WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd. · 2013 · 2 generations on0descendants
- K093739Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd. · 2010 · 2 generations on0descendants
- K090027Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107Zen Strong Medical Technology Co., Ltd. · 2009 · cites it directly0descendants
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) | K070473 | Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX | Zen Strong Medical Technology Co., Ltd. | 2007 | — |
| +1 | K091553 | Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper… | Ningbo Diaier Electronic Co., Ltd. | 2009 | — |
| +2 | K123839 | WA Series: WA100; WA200; WD100; WE100, WF100; WB200 | Ningbo Diaier Electronic Co., Ltd. | 2013 | — |
| +2 | K093739 | Blood Pressure Monitor/ Models | Ningbo Diaier Electronic Co., Ltd. | 2010 | — |
| +1 | K090027 | Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and… | Zen Strong Medical Technology Co., Ltd. | 2009 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K050249 | HL168JPSummary page 2…can be read out and keep memory on the LCD panel for home care use. 6. Comparison to the 510(k) Cleared Device (Predicate Device): 1> Health & Life model HL-168 (K050249). 2> Micro life model BP-3BTO-AP (K041411). 7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equiva… | 2005 |
| * | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APSummary page 2…nel for home care use. 6. Comparison to the 510(k) Cleared Device (Predicate Device): 1> Health & Life model HL-168 (K050249). 2> Micro life model BP-3BTO-AP (K041411). 7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to appl… | 2004 |
What descends from it? (4)
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 3.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K091553 (Ningbo Diaier Electronic Co., Ltd., 2009) has gone furthest, with 2 descendants of its own.
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. 2007, 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?
ZSBP-001 and ZSBP-002 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old.
ZSBP-101 series of 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 patient of the age over 18 years old.
All measurement values can be read out and keep memory on the LCD panel for home care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070473: Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070473
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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