510(k) · Cleared
ClearedUpper Arm Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Famidoc Technology Company Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 27, 2019 as substantially equivalent to K172895 (Ageless Health Industrial Co., Ltd., 2018) after a 156-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Nov 27, 2019
- Review
- 156 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K123882 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backK123882 Age Automatic Upper Arm Blood Pressure MonitorAgeless Health Industrial · 2013
- 2 generations backK153552 AGE Automatic Upper Arm Blood Pressure MonitorAgeless Health Industrial Co., Ltd. · 2016
- 1 generation backK172895 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815…Ageless Health Industrial Co., Ltd. · 2018
- This deviceK191673 Upper Arm Blood Pressure MonitorFamidoc Technology Company Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K123882 | Age Automatic Upper Arm Blood Pressure Monitor | Ageless Health Industrial | 2013 | — |
| −2 | K153552 | AGE Automatic Upper Arm Blood Pressure Monitor | Ageless Health Industrial Co., Ltd. | 2016 | — |
| −1 | K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816… | Ageless Health Industrial Co., Ltd. | 2018 | — |
| 0 (this device) | K191673 | Upper Arm Blood Pressure Monitor | Famidoc Technology Company Limited | 2019 | — |
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 |
|---|---|---|---|
| * | K172895 | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and…Summary page 5…Version: 1.1 3. Predicate Device: 510(K) Trade or Proprietary or Model Name Manufacturer K172895 AGE Automatic Upper Arm Blood Pressure Monitor Ageless Health Industrial Co., with Models BA-815, BA-816, BA-818 an… | 2018 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K172895.
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. 2019, 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?
FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191673: Upper Arm Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191673
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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