510(k) · Cleared
ClearedHL168JP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 30, 2005 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 30, 2005
- Review
- 55 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK050249 HL168JPHealth & Life Co., Ltd. · 2005
- Descendant · cites it directly · 4 of its ownK070473 Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK091553 Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300…Ningbo Diaier Electronic Co., Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK123839 WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK093739 Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd. · 2010
- Descendant · 2 generations on · 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 5 of 5 · See all- K070473Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd. · 2007 · cites it directly4descendants
- K091553Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm TypeNingbo Diaier Electronic Co., Ltd. · 2009 · 2 generations on2descendants
- K123839WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd. · 2013 · 3 generations on0descendants
- K093739Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd. · 2010 · 3 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050249 | HL168JP | Health & Life Co., Ltd. | 2005 | — |
| +1 | K070473 | Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX | Zen Strong Medical Technology Co., Ltd. | 2007 | — |
| +2 | K091553 | Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper… | Ningbo Diaier Electronic Co., Ltd. | 2009 | — |
| +3 | K123839 | WA Series: WA100; WA200; WD100; WE100, WF100; WB200 | Ningbo Diaier Electronic Co., Ltd. | 2013 | — |
| +3 | K093739 | Blood Pressure Monitor/ Models | Ningbo Diaier Electronic Co., Ltd. | 2010 | — |
| +2 | K090027 | Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and… | Zen Strong Medical Technology Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070473 | Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX | 2007 | 4 |
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?
- Of its descendants, K070473 (Zen Strong Medical Technology Co., Ltd., 2007) has gone furthest, with 4 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.
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?
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read cut in one LCD PANEL.
One or two readings will not provide a true indication of your normal blood pressure. It is very important to take regular, daily measurements and to keep accurate records at home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050249: HL168JP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050249
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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