510(k) · Cleared
ClearedFinapres Nova Noninvasive Hemodynamic Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Finapres Medical Systems B.V. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 20, 2015 as substantially equivalent to K023723 (Fms, Finapres Medical Systems BV, 2003) and 6 other predicates after a 291-day review. Its family tree reaches back 8 generations to 1991. 4 of the 83 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Mar 20, 2015
- Review
- 291 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K902859 (1991). 78 ancestors in all, the oldest K822055 (1982). 4 later devices descend from it, 2 citing it directly. 4 of the 83 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 6 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 5 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 4 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 3 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 2 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 1 generation backK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- This deviceK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- Descendant · cites it directly · 3 of its ownK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
- Descendant · cites it directly · 2 of its ownK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
- Descendant · 2 generations on · 0 of its ownK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK190228 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2019
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017 · cites it directly3descendants
- K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018 · cites it directly2descendants
- K223332Task Force CORECnsystems Medizintechnik GmbH · 2023 · 2 generations on0descendants
- K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −6 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −5 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −4 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −2 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −1 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| 0 (this device) | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | — |
| +1 | K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2017 | — |
| +1 | K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2018 | — |
| +2 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | — |
| +2 | K190228 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 2 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
4 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? (7)
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 |
|---|---|---|---|
| * | K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1Summary page 6…evice name Manufacturer 510(k) Finometer® Model-1 FMS, Finapres Medical Systems, K023723 Amsterdam, The Netherlands Ohmeda 2350 Finapres ® Blood Ohmeda Medical, Englewood… | 2003 |
| * | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure MonitorSummary page 6…, K023723 Amsterdam, The Netherlands Ohmeda 2350 Finapres ® Blood Ohmeda Medical, Englewood K880572 pressure monitor Portapres FMS, Finapres Medical Systems, K023338… | 1988 |
| * | K023338 | Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Summary page 6…s ® Blood Ohmeda Medical, Englewood K880572 pressure monitor Portapres FMS, Finapres Medical Systems, K023338 Amsterdam, The Netherlands NEXFIN_HDTM BMEYE B.V., Amsterdam, The… | 2003 |
| * | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Summary page 6…, K023338 Amsterdam, The Netherlands NEXFIN_HDTM BMEYE B.V., Amsterdam, The Netherlands K072049 Nellcor Oximax N-600X Pulse Nellcor Puriton Bennet, Inc, K060576 Oximeter… | 2007 |
| * | K060576 | Nellcor Oximax N-600X Pulse OximeterSummary page 6…FIN_HDTM BMEYE B.V., Amsterdam, The Netherlands K072049 Nellcor Oximax N-600X Pulse Nellcor Puriton Bennet, Inc, K060576 Oximeter Pleasanton Zoll M Series with real CPR help Zoll Medical Corporation, 269 Mill… | 2006 |
| * | K062537 | Zoll M Series with Real CPR HelpSummary page 6…riton Bennet, Inc, K060576 Oximeter Pleasanton Zoll M Series with real CPR help Zoll Medical Corporation, 269 Mill K062537 Road, Chelmsford MOVES THORNHILL RESEARCH INC, Toronto,… | 2007 |
| * | K093261 | MOVESSummary page 6…ation, 269 Mill K062537 Road, Chelmsford MOVES THORNHILL RESEARCH INC, Toronto, K093261 Ontario 4. Description The Finapres NOVA is an instrument to noninvasively monitor blood… | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K093261MOVESThornhill Research, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 18 of the 78 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K160967 (Finapres Medical Systems B.V., 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K023723.
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. 2015, 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 Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject’s finger. The Finapres NOV A provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from…
Read the full statement (214 words)
The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject’s finger. The Finapres NOV A provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from the flow signal requires a calibration with thermal dilution.
The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.
When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.
When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.
When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The Finapres NOVA is intended to be used for subjects above 18 years of age.
The Finapres NOVA is intended for use in a professional medical environment.
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/K141460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141460: Finapres Nova Noninvasive Hemodynamic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141460
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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