510(k) · Cleared
Recalled · Class II · 2015Task Force Monitor 3040
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cnsystems Medizintechnik GmbH · DSB Plethysmograph, Impedance
Cleared on Feb 7, 2002 as substantially equivalent to K001081 (Cardiodynamics International Corp., 2000) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1988. 1 of the 109 devices in its family, counting itself, has a Class I recall. 106 later devices descend from it. It has been recalled once.
- Decided
- Feb 7, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- DSB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880572 (1988). 2 ancestors in all. 106 later devices descend from it, 4 citing it directly. 1 of the 109 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK880572 Ohmeda 2350 Finapres (R) Blood Pressure MonitorOhmeda Medical · 1988
- This deviceK014063 Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002
- Descendant · cites it directly · 81 of its ownK023723 Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003
- Descendant · 2 generations on · 78 of its ownK072049 Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor…Bmeye B.V. · 2007
- Descendant · 3 generations on · 54 of its ownK101123 Nexfin Model 2Bmeye B.V. · 2010
- Descendant · 4 generations on · 53 of its ownK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- Descendant · 5 generations on · 52 of its ownK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…6 generations on · 2016
Most influential descendants
Showing 5 of 106 · See all- K023723Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003 · cites it directly81descendants
- K072049Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Bmeye B.V. · 2007 · 2 generations on78descendants
- K101123Nexfin Model 2Bmeye B.V. · 2010 · 3 generations on54descendants
- K122381Nexfin Model 2Edwards Lifesciences, LLC · 2013 · 4 generations on53descendants
- K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC · 2014 · 5 generations on52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure Monitor | Ohmeda Medical | 1988 | — |
| 0 (this device) | K014063 | Task Force Monitor 3040 | Cnsystems Medizintechnik GmbH | 2002 | — |
| +1 | K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1 | Fms, Finapres Medical Systems BV | 2003 | — |
| +2 | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with… | Bmeye B.V. | 2007 | — |
| +3 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| +4 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
| +5 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 1 |
| 2017 | 3 | 0 |
| 2018 | 8 | 0 |
| 2019 | 11 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 14 | 0 |
| 2024 | 7 | 0 |
| 2025 | 14 | 0 |
| 2026 | 8 | 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.
1 device in this family has a Class I recall. 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 DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K001081 | Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit…Summary page 4…model and manufacturer: Predicate device: CardioDynamics BioZ.pc Model: BZ-500/BZ-501 Manufacturer: CardioDynamics International Corporation Predicate Device 510(k): K001081 Reason for Submission: New device Predicate device: Ohmeda Finapres Model: 2350 Finapres Manufacturer: Ohmeda Medical Predic… | 2000 |
| * | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure MonitorSummary page 4…vice 510(k): K001081 Reason for Submission: New device Predicate device: Ohmeda Finapres Model: 2350 Finapres Manufacturer: Ohmeda Medical Predicate Device 510(Kk): K880572 Reason for Submission: New device The Task Force® Monitor 3040 is substantially equivalent to the BioZ.pc in terms of design, i… | 1988 |
What descends from it? (106)
See all 1064 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1 | 2003 | 81 |
| K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT | 2008 | 25 |
| K023338 | Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2 | 2003 | 8 |
| K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | 2017 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2015 | Class II | Z-0572-2016 | Mixed-up of materials/components | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, 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 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Task Force@Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's hemodynamic parameters using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). The TFM monitors continuously the subject's hemodynamic parameters without reporting any diagnosis.
Every measurement must be supervised by a medical trained professional. The Task Force@Monitol 3040 is a diagnosesaiding device and therefore not designed for vital sign monitoring or self-monitoring of patients.
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/K014063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014063: Task Force Monitor 3040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026