510(k) · Cleared
ClearedFB-100U Series Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fego Precision Industrial Co;, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 8, 2007 as substantially equivalent to K021225 (Rossmax International, Ltd., 2002) after a 198-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Aug 8, 2007
- Review
- 198 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021225 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021225 Rossmax Automatic Blood Pressure Monitor, Model Cardiocare 1000IRossmax International, Ltd. · 2002
- This deviceK070209 FB-100U Series Digital Blood Pressure MonitorFego Precision Industrial Co;, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021225 | Rossmax Automatic Blood Pressure Monitor, Model Cardiocare 1000I | Rossmax International, Ltd. | 2002 | — |
| 0 (this device) | K070209 | FB-100U Series Digital Blood Pressure Monitor | Fego Precision Industrial Co;, Ltd. | 2007 | — |
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 |
|---|---|---|---|
| * | K021225 | Rossmax Automatic Blood Pressure Monitor, Model Cardiocare 1000ISummary page 1…Regulation Number: 21CFR 870.1130 4. Predicate Device: The predicate device is the Rossmax Automatic Blood Pressure Monitor(K021225) marketed by ROSSMAX INTERNATIONAL LTD, 5. Device Description: FB-10OU Series DIGITAL Blood Pressure Monitor is designed to… | 2002 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K021225.
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. 2007, 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?
FB-10OU Series Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm.
The device is indicated for use by people over 15 years old in home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070209: FB-100U Series 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/K070209
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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