510(k) · Cleared
ClearedContinuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bmeye B.V. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 29, 2007 as substantially equivalent to K023723 (Fms, Finapres Medical Systems BV, 2003) after a 127-day review. Its family tree reaches back 3 generations to 1988. 1 of the 84 devices in its family, counting itself, has a Class I recall. 78 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K880572 (1988). 5 ancestors in all, the oldest K822055 (1982). 78 later devices descend from it, 6 citing it directly. 1 of the 84 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK880572 Ohmeda 2350 Finapres (R) Blood Pressure MonitorOhmeda Medical · 1988
- 2 generations backK014063 Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002 · Recalled
- 1 generation backK023723 Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003
- This deviceK072049 Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor…Bmeye B.V. · 2007
- Descendant · cites it directly · 54 of its ownK101123 Nexfin Model 2Bmeye B.V. · 2010
- Descendant · 2 generations on · 53 of its ownK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- Descendant · 3 generations on · 52 of its ownK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- Descendant · 4 generations on · 51 of its ownK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- Descendant · 5 generations on · 41 of its ownK163381 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2017 · Recalled
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…4 generations on · 2016
Most influential descendants
Showing 5 of 78 · See all- K101123Nexfin Model 2Bmeye B.V. · 2010 · cites it directly54descendants
- K122381Nexfin Model 2Edwards Lifesciences, LLC · 2013 · 2 generations on53descendants
- K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC · 2014 · 3 generations on52descendants
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC · 2016 · 4 generations on51descendants
- K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC · 2017 · 5 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure Monitor | Ohmeda Medical | 1988 | — |
| −2 | K014063 | Task Force Monitor 3040 | Cnsystems Medizintechnik GmbH | 2002 | 1 |
| −1 | K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1 | Fms, Finapres Medical Systems BV | 2003 | — |
| 0 (this device) | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with… | Bmeye B.V. | 2007 | — |
| +1 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| +2 | 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 |
| +4 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| +5 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2017 | 2 |
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 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 1 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 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 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? (1)
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 1…essure, non-invasive, DXN Name - CFR 870.2770, Plethysmograph, impedance, DSB Predicate: The NEXFINHD is substantially equivalent to the Finometer (K023723). Device The BMEYE NEXFIN HD cardiovascular monitor is a non-invasive monitor that description enables the con… | 2003 |
What descends from it? (78)
See all 786 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101123 | Nexfin Model 2 | 2010 | 54 |
| K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs… | 2016 | 16 |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs… | 2017 | 15 |
| K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | 2015 | 4 |
| K091564 | NBM-200MP Pulse Oximetry Device | 2010 | 2 |
| K213699 | CareTaker Monitor App | 2022 | 0 |
Has anything in its family been recalled? (1 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 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K101123 (Bmeye B.V., 2010) has gone furthest, with 54 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. 2007, 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 BMEYE NEXFIN._HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFINHD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is Intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072049
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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