510(k) · Cleared
ClearedXM-01 Electronic Automatic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sky Innovation Technology ( Shanghai) Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 16, 2015 as substantially equivalent to K123669 (Zhongshan Transtek Electronics Co., Ltd., 2012) after a 257-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Dec 16, 2015
- Review
- 257 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042505 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 2 generations backK122482 Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- 1 generation backK123669 Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- This deviceK150908 XM-01 Electronic Automatic Blood Pressure MonitorSky Innovation Technology ( Shanghai) Limited · 2015
- Descendant · cites it directly · 0 of its ownK222394 Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222394Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −2 | K122482 | Transtek Wrist Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| −1 | K123669 | Transtek Wrist Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| 0 (this device) | K150908 | XM-01 Electronic Automatic Blood Pressure Monitor | Sky Innovation Technology ( Shanghai) Limited | 2015 | — |
| +1 | K222394 | Electronic Sphygmomanometers | Qingdao Yasee Medical Device Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K123669 | Transtek Wrist Blood Pressure MonitorSummary page 4…II Regulation Number: 21 CFR 870.1130 Panel: General Cardiovascular Product Code: DXN 5.5 Predicate Device Information: (1) K123669, “Transtek Wrist Blood Pressure Monitor”, manufactured by “Zhongshan Transtek Electronics Co., Ltd.” 5.6 Device Descri… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222394 | Electronic Sphygmomanometers | 2023 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K222394 (Qingdao Yasee Medical Device Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123669.
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. 2015, 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?
XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150908: XM-01 Electronic Automatic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150908
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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