510(k) · Cleared
ClearedPG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Pango Electronic Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 30, 2013 as substantially equivalent to K102988 (Shenzhen Pango Electronic Co., Ltd., 2010) after a 92-day review. Its family tree reaches back 4 generations to 2000. 22 later devices descend from it.
- Decided
- Aug 30, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001670 (2000). 22 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 3 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 2 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 1 generation backK102988 Electronic Blood Presure MonitorShenzhen Pango Electronic Co., Ltd. · 2010
- This deviceK131558 PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3…Shenzhen Pango Electronic Co., Ltd. · 2013
- Descendant · cites it directly · 19 of its ownK170151 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2017
- Descendant · 2 generations on · 11 of its ownK182495 Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. · 2019
- Descendant · 3 generations on · 10 of its ownK191180 Electronic Blood Pressure MonitorShenzhen AOJ Medical Technology Co., Ltd. · 2019
- Descendant · 4 generations on · 4 of its ownK222125 Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK183058 Arm-type Electronic Blood Pressure MonitorShenzhen Bsx Technology Electronics Co., Ltd. · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K170151Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2017 · cites it directly19descendants
- K182495Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. · 2019 · 2 generations on11descendants
- K191180Electronic Blood Pressure MonitorShenzhen AOJ Medical Technology Co., Ltd. · 2019 · 3 generations on10descendants
- K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F…Shenzhen AOJ Medical Technology Co., Ltd. · 2022 · 4 generations on4descendants
- K183058Arm-type Electronic Blood Pressure MonitorShenzhen Bsx Technology Electronics Co., Ltd. · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −3 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −2 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −1 | K102988 | Electronic Blood Presure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2010 | — |
| 0 (this device) | K131558 | PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4… | Shenzhen Pango Electronic Co., Ltd. | 2013 | — |
| +1 | K170151 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017 | — |
| +2 | K182495 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019 | — |
| +3 | K191180 | Electronic Blood Pressure Monitor | Shenzhen AOJ Medical Technology Co., Ltd. | 2019 | — |
| +4 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D… | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +2 | K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 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 |
|---|---|---|---|
| * | K102988 | Electronic Blood Presure MonitorSummary page 2…upper ann. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm. 5. Predicate Device Identification 510(k) Number: K102988 Product Name: Electronic Blood Pressure Monitor, PG-800B Manufacturer: Shenzhen Pango Electironic Co., Ltd 6. Devic… | 2010 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170151 (Shenzhen Pango Electronic Co., Ltd., 2017) has gone furthest, with 19 descendants of its own.
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. 2013, 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?
Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131558: PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131558
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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