510(k) · Cleared
ClearedBP 101 Digital Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kingyield Hongkong Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 23, 2007 as substantially equivalent to K001670 (Omron Healthcare, Inc., 2000) after a 248-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Mar 23, 2007
- Review
- 248 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001670 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- This deviceK062033 BP 101 Digital Blood Pressure MonitorKingyield Hongkong Limited · 2007
- Descendant · cites it directly · 3 of its ownK080206 Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 2008
- Descendant · 2 generations on · 0 of its ownK192413 SiteSeal Femoral Compression DeviceEnsite Vacular, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK120204 Reprocessed Femoral Compression DeviceSterilmed, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK110193 Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II…St. Jude Medical Systems AB · 2011
Most influential descendants
Showing 4 of 4 · See all- K080206Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 2008 · cites it directly3descendants
- K192413SiteSeal Femoral Compression DeviceEnsite Vacular, LLC · 2020 · 2 generations on0descendants
- K120204Reprocessed Femoral Compression DeviceSterilmed, Inc. · 2012 · 2 generations on0descendants
- K110193Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II…St. Jude Medical Systems AB · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| 0 (this device) | K062033 | BP 101 Digital Blood Pressure Monitor | Kingyield Hongkong Limited | 2007 | — |
| +1 | K080206 | Modification to Femostop Femoral Compression System | Radi Medical Systems AB | 2008 | — |
| +2 | K192413 | SiteSeal Femoral Compression Device | Ensite Vacular, LLC | 2020 | — |
| +2 | K120204 | Reprocessed Femoral Compression Device | Sterilmed, Inc. | 2012 | — |
| +1 | K110193 | Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set… | St. Jude Medical Systems AB | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Summary page 1…DXN 5.Classification Panel: Cardiovascular 6. Predicate Device: BEM-757 AUtomatic Digital Blood Pressure Monitor with Intelligence marketed by Omron Healthcare INC. K 00 1670 (Predicate) 7.Device Description: BPI101 Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monit… | 2000 |
What descends from it? (4)
2 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?
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?
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062033: BP 101 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/K062033
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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