510(k) · Cleared
ClearedBioland Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioland Technology, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 16, 2009 as substantially equivalent to K032499 (A&D Engineering, Inc., 2003) and 2 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Jan 16, 2009
- Review
- 35 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K871718 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK871718 Modified Model UA-711 Digital SphygmonometerA&D Engineering, Inc. · 1987
- 1 generation backK032499 A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsA&D Engineering, Inc. · 2003
- This deviceK083681 Bioland Blood Pressure MonitorBioland Technology, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK111141 Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure MonitorWenzhou Bokang Instruments Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K111141Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure MonitorWenzhou Bokang Instruments Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871718 | Modified Model UA-711 Digital Sphygmonometer | A&D Engineering, Inc. | 1987 | — |
| −1 | K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors | A&D Engineering, Inc. | 2003 | — |
| 0 (this device) | K083681 | Bioland Blood Pressure Monitor | Bioland Technology, Ltd. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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…redicate Device: // A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499), A & D LifeSource UB-328 Digital Blood Pressure Monitor (K040229) A & D Medical UA-767BT Digital Blood Pressure Monitor (k040371… | 2003 |
| * | K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328Summary page 1…// A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499), A & D LifeSource UB-328 Digital Blood Pressure Monitor (K040229) A & D Medical UA-767BT Digital Blood Pressure Monitor (k040371)… | 2004 |
| * | K040371 | A & D Medical UA-767BT Digital Blood Pressure MonitorSummary page 1…UA-704 Digital Blood Pressure Monitor (K032499), A & D LifeSource UB-328 Digital Blood Pressure Monitor (K040229) A & D Medical UA-767BT Digital Blood Pressure Monitor (k040371) -201 - Pr… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111141 | Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure Monitor | 2012 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 16.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K111141 (Wenzhou Bokang Instruments Co., Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 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. 2009, 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?
Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometer with Electronic Manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate for adults only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083681: Bioland 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/K083681
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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