510(k) · Cleared
ClearedBlood Pressure Monitor (W06LT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Jamr Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 20, 2026 as substantially equivalent to K230409 (Shenzhen Jamr Technology Co., Ltd., 2023) after a 184-day review. Its family tree reaches back 13 generations to 2000.
- Decided
- May 20, 2026
- Review
- 184 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K001670 (2000). 24 ancestors in all, the oldest K982481 (1998). No later device cites it as a predicate yet.
- Root · 13 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 9 generations between
- 3 generations backK171833 Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018
- 2 generations backK220651 Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd. · 2022
- 1 generation backK230409 Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd. · 2023
- This deviceK253570 Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 12 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 11 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 10 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 9 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 8 generations backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 7 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 6 generations backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- 5 generations backK140067 QardioarmQardio, Inc. · 2014
- 4 generations backK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
- 3 generations backK171833 Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018
- 2 generations backK220651 Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd. · 2022
- 1 generation backK230409 Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd. · 2023
- This deviceK253570 Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −12 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −11 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −10 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −9 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −8 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −7 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| −6 | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| −5 | K140067 | Qardioarm | Qardio, Inc. | 2014 | — |
| −4 | K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | Fudakang Industrial Co., Ltd. | 2015 | — |
| −3 | K171833 | Digital Blood Pressure Monitor-Wrist Style | Shenzhen Combei Technology Co., Ltd. | 2018 | — |
| −2 | K220651 | Wrist Type Blood Pressure Monitor | Shenzhen Jamr Medical Technology Co., Ltd. | 2022 | — |
| −1 | K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L) | Shenzhen Jamr Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L)Summary page 5…ion name: System, Measurement, Blood-Pressure, Non-Invasive Product Code: DXN Device Class: II Regulation Number:870.1130 3. Predicate Device Information 510(K) Number: K230409 Trade Name: Wrist Type Blood Pressure Monitor Model(s): W05,W1101L Classification name: System, Measurement, Blood-Pressure, Non-… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- None of the 24 ancestors has a recall.
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. 2026, 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?
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the
pulse rate of adults of adults by using the wrist cuff. The device can be used in medical facilities or at home,
and only for indoor use. It is supplied for OTC use. The device is not intended for use in patients with
arrhythmias or in pregnant patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253570 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253570: Blood Pressure Monitor (W06LT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253570
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026