510(k) · Cleared
ClearedElectronic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hetaida Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 7, 2025 as substantially equivalent to K223170 (Hetaida Technology Co., Ltd., 2023) after a 72-day review. Its family tree reaches back 6 generations to 2005.
- Decided
- Feb 7, 2025
- Review
- 72 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K052153 (2005). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 5 generations backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- 4 generations backK133383 HEM-7320Omron Healthcare, Inc. · 2014
- 3 generations backK170605 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2018
- 2 generations backK200939 Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020
- 1 generation backK223170 Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd. · 2023
- This deviceK243661 Electronic Blood Pressure MonitorHetaida Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −5 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| −4 | K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014 | — |
| −3 | K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood… | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018 | — |
| −2 | K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020 | — |
| −1 | K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K223170 | Electronic Blood Pressure Monitor, model: HTD6602USSummary page 5…and LCD. Cuffs including cuff of size 22cm~32cm and cuff of size 22cm~42cm. 3. Predicate Device Identification 510(k) Number: K223170 Product Name: Electronic Blood Pressure Monitor Model Name: HTD6602US Submitter: Hetaida Technolo… | 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 20 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 7 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. 2025, 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?
This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243661: Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243661
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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