510(k) · Cleared
ClearedBP Pro Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 23, 2005 as substantially equivalent to K041313 (I.E.M. GmbH, 2004) after a 17-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Dec 23, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021682 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK021682 Omron Automatic Blood Pressure Monitor with Intellisense, Models…Omron Healthcare, Inc. · 2002
- 1 generation backK041313 Stabil-O-GraphI.E.M. GmbH · 2004
- This deviceK053395 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK060703 PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060703PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021682 | Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773… | Omron Healthcare, Inc. | 2002 | — |
| −1 | K041313 | Stabil-O-Graph | I.E.M. GmbH | 2004 | — |
| 0 (this device) | K053395 | BP Pro Blood Pressure Monitor | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K060703 | PMP4 BP Pro Blood Pressure Monitor | Card Guard Scientific Survival, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K041313 | Stabil-O-GraphSummary page 1…easurement System Product Code: DXN Regulation Number: 21 CFR 870.113 0 Class: It Predicate Devices: k041313 Stahil-O-Grapb, Blood Pressure Monitor by L.EM. Device Description: The BP Pro Blood Pressure Monitor is a fully automatic tabl… | 2004 |
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 |
|---|---|---|---|
| K060703 | PMP4 BP Pro Blood Pressure Monitor | 2006 | 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 3 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060703 (Card Guard Scientific Survival, Ltd., 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041313.
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.
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?
BP Pro is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic)
and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches
(24 cm to 42 cm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053395: BP Pro Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053395
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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