510(k) · Cleared
ClearedBpcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qrs Diagnostic, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 5, 2003 as substantially equivalent to K913844 (Suntech Medical Instruments, Inc., 1992) after a 72-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Sep 5, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913844 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913844 Accutracker DXSuntech Medical Instruments, Inc. · 1992
- This deviceK031964 BpcardQrs Diagnostic, LLC · 2003
- Descendant · cites it directly · 2 of its ownK073630 Modification to: Bpcard, Model Z-7000-0700Qrs Diagnostic, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK103703 Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK120131 Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913844 | Accutracker DX | Suntech Medical Instruments, Inc. | 1992 | — |
| 0 (this device) | K031964 | Bpcard | Qrs Diagnostic, LLC | 2003 | — |
| +1 | K073630 | Modification to: Bpcard, Model Z-7000-0700 | Qrs Diagnostic, LLC | 2008 | — |
| +2 | K103703 | Reguis Sigma | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +3 | K120131 | Regius SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K913844 | Accutracker DXSummary page 2…ww.QRSdiagnostic.com C. Identification of Legally Marketed Devices 1. Name: Accutracker DX 2. K Number: K913844 3. Date Cleared: July 14, 1992 D. Description of the Device The BPCardTMis a non-invasive Blood Press… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073630 | Modification to: Bpcard, Model Z-7000-0700 | 2008 | 2 |
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.
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?
The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in-patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031964: Bpcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031964
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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