510(k) · Cleared
ClearedAmbulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contec Medical System Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 27, 2011 as substantially equivalent to K091068 (Datascope Corp., Patient Monitoring Division, 2009) after a 189-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jul 27, 2011
- Review
- 189 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983575 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK983575 Accutorr Plus Non Invasive Blood Pressure Monitor, Model #…Datascope Corp. · 1999
- 1 generation backK091068 Accutorr V Monitor, Model 0998-00-2000Datascope Corp., Patient Monitoring Division · 2009 · Recalled
- This deviceK110156 Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,Contec Medical System Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983575 | Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX | Datascope Corp. | 1999 | — |
| −1 | K091068 | Accutorr V Monitor, Model 0998-00-2000 | Datascope Corp., Patient Monitoring Division | 2009 | 1 |
| 0 (this device) | K110156 | Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer, | Contec Medical System Co., Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K091068 | Accutorr V Monitor, Model 0998-00-2000Summary page 2…mmary cuff is wrapped around the upper ann. It can be used on adult, pediatric and neonatal individuals. 5. Predicate Device Identification 510(k) Number: K091068 Product Name: Accutorr V Monitor Manufacturer: Datascope Patient Monitoring, Mindray DS USA, Inc. 6. Device Description… | 2009 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K091068.
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?
ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110156: Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110156
Report an extraction error
Are you the manufacturer?
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