510(k) · Cleared
ClearedHX-461
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seers Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 23, 2012 as substantially equivalent to K043217 (A&D Engineering, Inc., 2005) after a 243-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Oct 23, 2012
- Review
- 243 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982481 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK982481 A&D Medical UA-767PC Digital Blood Pressure MonitorA&D Engineering, Inc. · 1998
- 2 generations backK040371 A & D Medical UA-767BT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2004
- 1 generation backK043217 A&D Medical UA-767PBT Digital Blood Pressure MonitorA&D Engineering, Inc. · 2005 · Recalled
- This deviceK120545 HX-461Seers Technology Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | A&D Engineering, Inc. | 1998 | — |
| −2 | K040371 | A & D Medical UA-767BT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2004 | — |
| −1 | K043217 | A&D Medical UA-767PBT Digital Blood Pressure Monitor | A&D Engineering, Inc. | 2005 | 1 |
| 0 (this device) | K120545 | HX-461 | Seers Technology Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorSummary page 1…lation: 21 CFR 870.1130 & 21 CFR88O.63 10 Class of device : ClasslI. 2. The legally marketed device to which we are claiming equivalence: UA-789 & UA-767PBT(K0432 17) 3. Description of device: HX-461 applies the oscillometric method to measure patient blood pressure. It is composed o… | 2005 |
| * | — | UA-789 Named without a submission number |
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 14 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 11 other devices also cite its predicate K043217.
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. 2012, 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?
HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user registration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood glucose and body fat measurement values by connecting with respective measurement…
Read the full statement (123 words)
HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user registration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood glucose and body fat measurement values by connecting with respective measurement instruments supporting Bluetooth connection, or by docking a blood glucose meter on its back. In addition, HX-461 supports wired/wireless communication with a designated person including video communication.. It has three size of cuff for blood pressure measurement. User chooses the cuff depending on their arm circumference.
Cuff size Arm Circumference
D-cuff Small :18-22cm
D-cuff Adult :22-32cm
D-cuff Large 32-45cm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120545: HX-461.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120545
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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