510(k) · Cleared
ClearedBlood Pressure Monitor (BBZ32-AA01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Transtek Medical Electronics Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 7, 2024 as substantially equivalent to K133379 (Omron Healthcare, Inc., 2014) after a 73-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Jun 7, 2024
- Review
- 73 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052153 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 2 generations backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- 1 generation backK133379 HEM-7311Omron Healthcare, Inc. · 2014
- This deviceK240832 Blood Pressure Monitor (BBZ32-AA01)Guangdong Transtek Medical Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK253124 Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −2 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| −1 | K133379 | HEM-7311 | Omron Healthcare, Inc. | 2014 | — |
| 0 (this device) | K240832 | Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024 | — |
| +1 | K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K133379 | HEM-7311Summary page 5…care, Inc. Device Name / Model: Noninvasive blood pressure measurement system / HEM-7311 510(k) Number: K133379 Classification Class Ⅱ Product Code DXN 4. Device Description Blood Pressure Monitor BB… | 2014 |
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 |
|---|---|---|---|
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | 2026 | 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 19 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253124 (Shenzhen Ziqing Medical Equipment Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K133379.
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. 2024, 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?
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and
pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm
(about 8¾"-16½").
It is intended for adult indoor use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240832: Blood Pressure Monitor (BBZ32-AA01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240832
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