510(k) · Cleared
ClearedTask Force CORE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cnsystems Medizintechnik GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 12, 2023 as substantially equivalent to K173916 (Finapres Medical Systems B.V., 2018) and 1 other predicate after a 163-day review. Its family tree reaches back 12 generations to 2000. 5 of the 106 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 12, 2023
- Review
- 163 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K000126 (2000). 105 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet. 5 of the 106 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 8 generations between
- 3 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 2 generations backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- 1 generation backK183521 CNAP MonitorCnsystems Medizintechnik GmbH · 2019
- This deviceK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
Show all 12 generations
- Root · 12 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 11 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 10 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 9 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
- 8 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- 7 generations backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- 6 generations backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 5 generations backK101123 Nexfin Model 2Bmeye B.V. · 2010
- 4 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 3 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 2 generations backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- 1 generation backK183521 CNAP MonitorCnsystems Medizintechnik GmbH · 2019
- This deviceK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −11 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −10 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −9 | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | 1 |
| −8 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| −7 | K061204 | Masimo Set Radical 7 Pulse CO-Oximeter | Masimo Corporation | 2006 | — |
| −6 | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | 1 |
| −5 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| −4 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
| −3 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| −2 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| −1 | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | — |
| 0 (this device) | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 1 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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.
5 devices in this family have 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 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? (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 |
|---|---|---|---|
| * | K173916 | Finapres Nova Noninvasive Hemodynamic MonitorSummary page 5…s Medizintechnik GmbH Technical Documentation – Task Force® CORE 5.4 Predicate Devices 5.4.1 Primary predicate device (PPD): Finapres NOVA: K173916 Manufacturer: Finapres Medical Systems B.V. Hogehilweg 8, 1101 CC Amster… | 2018 |
| * | K183521 | CNAP MonitorSummary page 5…he Finapres NOVA share the same intended use and the same fields of application in the market. 5.4.2 Secondary predicate device (SPD): CNAP® Monitor 500 HD: K183521 Manufacturer: CNSystems Medizintechnik GmbH Graz, Austria The CNAP® Monitor 500HD is a s… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 24 of the 105 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K173916.
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. 2023, this device’s year, is highlighted.
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 Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters. The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator. The TFC contains software which runs on a separate…
Read the full statement (125 words)
The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters.
The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator.
The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products.
The TFC can provide all signals as well as measured and derived parameters to the analog output interface and can acquire signals from the analog input interface.
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/K223332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223332: Task Force CORE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223332
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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