510(k) · Cleared
ClearedBokang Semi-Auto / Automatic / Wrist Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzhou Bokang Instruments Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 21, 2012 as substantially equivalent to K032499 (A&D Engineering, Inc., 2003) and 1 other predicate after a 305-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Feb 21, 2012
- Review
- 305 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K871718 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
- 2 generations backK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
- 1 generation backK083681 Bioland Blood Pressure MonitorBioland Technology, Ltd. · 2009
- This deviceK111141 Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure MonitorWenzhou Bokang Instruments Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871718 | Modified Model UA-711 Digital Sphygmonometer | A&D Engineering, Inc. | 1987 | — |
| −2 | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2003 | — |
| −1 | K083681 | Bioland Blood Pressure Monitor | Bioland Technology, Ltd. | 2009 | — |
| 0 (this device) | K111141 | Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure Monitor | Wenzhou Bokang Instruments Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsSummary page 1…measurement system. ____ Predicate Device A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499) Bioland Blood Pressure Monitor Model 2001, 2003, 3000 (K083681) Description and Indication for Use Bokang Digital Blood Pressur… | 2003 |
| * | K083681 | Bioland Blood Pressure MonitorSummary page 1…____ Predicate Device A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499) Bioland Blood Pressure Monitor Model 2001, 2003, 3000 (K083681) Description and Indication for Use Bokang Digital Blood Pressure Monitor are non-invasive blood pressure (NLBP) monitors which… | 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 25 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K032499.
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?
Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023 are non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate by using an inflating cuff which is wrapped around the upper arm or wrist. The device is indicated for use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111141: Bokang Semi-Auto / Automatic / Wrist Digital 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/K111141
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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