510(k) · Cleared
ClearedAccumed Upper Arm Automatic Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accumed Healthcare (Shanghai), Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 22, 2011 as substantially equivalent to K100553 (Citizen Systems Japan Co., Ltd., 2010) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Nov 22, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K100553 (2010). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK100553 Blood Pressure Meter Model CH-101Citizen Systems Japan Co., Ltd. · 2010
- This deviceK112273 Accumed Upper Arm Automatic Blood Pressure MonitorAccumed Healthcare (Shanghai), Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100553 | Blood Pressure Meter Model CH-101 | Citizen Systems Japan Co., Ltd. | 2010 | — |
| 0 (this device) | K112273 | Accumed Upper Arm Automatic Blood Pressure Monitor | Accumed Healthcare (Shanghai), Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K100553 | Blood Pressure Meter Model CH-101Summary page 1…CFR 870.1130 Product Code DXN Predicate Device: Citizen CH-1O1, K100553, Citizen CH-609, K100055 Date Summary Prepared:… | 2010 |
| * | K100055 | Blood Pressure Meter, Model CH-609Summary page 1…DXN Predicate Device: Citizen CH-1O1, K100553, Citizen CH-609, K100055 Date Summary Prepared: Nov 7, 2011 Device Description: The Accumned Upper Arm Automatic Blood… | 2010 |
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?
- None of the 2 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. 2011, 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 Accumned Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate. using the oscillometric method for adults at home.
The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112273: Accumed Upper Arm Automatic 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/K112273
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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