510(k) · Cleared
Recalled · Class II · 2012Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fms, Finapres Medical Systems BV · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 9, 2003 as substantially equivalent to K822055 (Ohio Medical Products, 1982) and 2 other predicates after a 214-day review. Its family tree reaches back 2 generations to 1988. 8 later devices descend from it. It has been recalled once.
- Decided
- May 9, 2003
- Review
- 214 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K880572 (1988). 4 ancestors in all, the oldest K822055 (1982). 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK880572 Ohmeda 2350 Finapres (R) Blood Pressure MonitorOhmeda Medical · 1988
- 1 generation backK014063 Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002 · Recalled
- This deviceK023338 Portapres Ambulatory Continuous Non Invasive Blood Pressure…Fms, Finapres Medical Systems BV · 2003
- Descendant · cites it directly · 4 of its ownK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- Descendant · 2 generations on · 3 of its ownK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
- Descendant · 2 generations on · 2 of its ownK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
- Descendant · cites it directly · 1 of its ownK093981 Yrnsortip OximanometerCnoga Medical, Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015 · cites it directly4descendants
- K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017 · 2 generations on3descendants
- K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018 · 2 generations on2descendants
- K093981Yrnsortip OximanometerCnoga Medical, Ltd. · 2010 · cites it directly1descendant
- K223332Task Force CORECnsystems Medizintechnik GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure Monitor | Ohmeda Medical | 1988 | — |
| −1 | K014063 | Task Force Monitor 3040 | Cnsystems Medizintechnik GmbH | 2002 | 1 |
| 0 (this device) | K023338 | Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2 | Fms, Finapres Medical Systems BV | 2003 | — |
| +1 | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | — |
| +2 | K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2017 | — |
| +2 | K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2018 | — |
| +1 | K093981 | Yrnsortip Oximanometer | Cnoga Medical, Ltd. | 2010 | — |
| +3 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K822055 | Cnibp Blood Pressure Measurement SysSummary page 2…0 Ohmeda 2300 FinapresB Blood Pressure Monitor, Ohmeda - - Medical, Englewood, CO 801 12-5810, K822055 0 Ohmeda 2350 FinapresB Blood Pressure Monitor, Ohmeda Medicid, Englewood, CO 801 12-5810, K880572 0 Task For… | 1982 |
| * | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure MonitorSummary page 2…Medical, Englewood, CO 801 12-5810, K822055 0 Ohmeda 2350 FinapresB Blood Pressure Monitor, Ohmeda Medicid, Englewood, CO 801 12-5810, K880572 0 Task Force Monitor 3040, CNSystems Medizintechnik GMBH, Europe, AU, KO 14063 (Beatscope software): RODA M… | 1988 |
| * | K014063 | Task Force Monitor 3040 | 2002 |
| † | K011238 | Roda (Real Time Oxygen Dynamics Analysis) Monitoring System | 2002 |
What descends from it? (8)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2012 | Class II | Z-2150-2012 | Process control | Battery may become hot and leak |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K141460 (Finapres Medical Systems B.V., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K822055.
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 Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring.
The Portapres enables 24-hour continuous ambulatory measurements.
The PC-based Beatscope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023338: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023338
Report an extraction error
Are you the manufacturer?
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