510(k) · Cleared
ClearedABP-2000 G-3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotrac, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 12, 2002 as substantially equivalent to K012647 (Par Medizintechnik GmbH, 2001) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Apr 12, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K855127 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
- 2 generations backK964235 Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlIndustrielle Entwicklung Medizintechnik Und Vertri · 1999
- 1 generation backK012647 Tonoport VPar Medizintechnik GmbH · 2001
- This deviceK021029 ABP-2000 G-3Biotrac, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202 | Spacelabs, Inc. | 1986 | — |
| −2 | K964235 | Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control | Industrielle Entwicklung Medizintechnik Und Vertri | 1999 | — |
| −1 | K012647 | Tonoport V | Par Medizintechnik GmbH | 2001 | — |
| 0 (this device) | K021029 | ABP-2000 G-3 | Biotrac, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K012647 | Tonoport VSummary page 1…or Classification name: 21 CFR 870.1130 Non-Invasive Blood-Pressure Measurement System (DXN). ‘Class 11, Circulatory System Devices Panel (74) 3.- Predicate Devices K012647, Tonoport V, PAR Medizintechnik GmbH. K003004, Oscar 2, SunTech Medical Instruments. K021029 pl/3 K964235, ABPM Mobil-0-Graph B… | 2001 |
| * | K003004 | Oscar 2, Model 222Summary page 1…nvasive Blood-Pressure Measurement System (DXN). ‘Class 11, Circulatory System Devices Panel (74) 3.- Predicate Devices K012647, Tonoport V, PAR Medizintechnik GmbH. K003004, Oscar 2, SunTech Medical Instruments. K021029 pl/3 K964235, ABPM Mobil-0-Graph Blood Pressure Monitor, .LE.M. GmbH. The ABP-2… | 2000 |
| * | K964235 | Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlSummary page 1…Circulatory System Devices Panel (74) 3.- Predicate Devices K012647, Tonoport V, PAR Medizintechnik GmbH. K003004, Oscar 2, SunTech Medical Instruments. K021029 pl/3 K964235, ABPM Mobil-0-Graph Blood Pressure Monitor, .LE.M. GmbH. The ABP-2000 G-3 is substantially equivalent to these devices. === Pag… | 1999 |
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 16 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K012647.
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?
It is intended to be used as an aid or support for the initial diagnosis and subsequent treatment’s follow-up when it is necessary to measure a patient’s blood pressure over a determined period of time. The system does not make any diagnose, it only measures, stores and displays the information. The ABP-2000 G-3 (NIBP) monitor is only intended and designed: - for measuring the systolic, diastolic and mean blood pressure as well as the heart rate of human…
Read the full statement (121 words)
It is intended to be used as an aid or support for the initial diagnosis and subsequent treatment’s follow-up when it is necessary to measure a patient’s blood pressure over a determined period of time. The system does not make any diagnose, it only measures, stores and displays the information. The ABP-2000 G-3 (NIBP) monitor is only intended and designed:
- for measuring the systolic, diastolic and mean blood pressure as well as the heart rate of human beings.
- for recording during a predetermined period of time the above mentioned measurements (up to 250 measurements).
- to be used along with the ABP-2000 G-3 software for programming as well as record keeping and display in a graphical or tabular report.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021029: ABP-2000 G-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021029
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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