510(k) · Cleared
ClearedMytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, HPL-301, HPL-302, HPL-310, 180310
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mytech Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 22, 2006 as substantially equivalent to K030221 (Mytech Technology Co., Ltd., 2003) after a 42-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Aug 22, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030221 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030221 Mytech / Happy Life Blood Pressure MonitorMytech Technology Co., Ltd. · 2003
- This deviceK061959 Mytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, HPL-301…Mytech Technology Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030221 | Mytech / Happy Life Blood Pressure Monitor | Mytech Technology Co., Ltd. | 2003 | — |
| 0 (this device) | K061959 | Mytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, HPL-301, HPL-302… | Mytech Technology Co., Ltd. | 2006 | — |
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 |
|---|---|---|---|
| * | K030221 | Mytech / Happy Life Blood Pressure MonitorSummary page 1…VASCULAR Product code: DXN Legally Marketed MYTECH/HAPPYLJFEARMBLOOD (Predicate)PRESSURE MONITOR, HPL3001/HPL300A Device:51 0(k) No: K030221 El Description of the new device: B… | 2003 |
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?
- Its one ancestor has no 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.
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 MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor, Model HPL-301, HPL-302, HPL-310, 180310 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
The cuff circumference is limited to be 7"-15".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061959 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061959: Mytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, HPL-301, HPL-302, HPL-310, 180310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061959
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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