510(k) · Cleared
ClearedFinometer Noninvasive Hemodynamic Monitor, Model 1
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 Oct 23, 2003 as substantially equivalent to K822055 (Ohio Medical Products, 1982) and 2 other predicates after a 352-day review. Its family tree reaches back 2 generations to 1988. 1 of the 86 devices in its family, counting itself, has a Class I recall. 81 later devices descend from it.
- Decided
- Oct 23, 2003
- Review
- 352 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K880572 (1988). 4 ancestors in all, the oldest K822055 (1982). 81 later devices descend from it, 3 citing it directly. 1 of the 86 devices in this family, counting this one, has a Class I recall.
- 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 deviceK023723 Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003
- Descendant · cites it directly · 78 of its ownK072049 Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor…Bmeye B.V. · 2007
- Descendant · 2 generations on · 54 of its ownK101123 Nexfin Model 2Bmeye B.V. · 2010
- Descendant · 3 generations on · 53 of its ownK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- Descendant · 4 generations on · 52 of its ownK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- Descendant · 5 generations on · 51 of its ownK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…5 generations on · 2016
Most influential descendants
Showing 5 of 81 · See all- K072049Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Bmeye B.V. · 2007 · cites it directly78descendants
- K101123Nexfin Model 2Bmeye B.V. · 2010 · 2 generations on54descendants
- K122381Nexfin Model 2Edwards Lifesciences, LLC · 2013 · 3 generations on53descendants
- K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC · 2014 · 4 generations on52descendants
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC · 2016 · 5 generations on51descendants
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) | K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1 | Fms, Finapres Medical Systems BV | 2003 | — |
| +1 | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with… | Bmeye B.V. | 2007 | — |
| +2 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| +3 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
| +4 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| +5 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 1 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 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? (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…following devices that have been or still are in commercial distribution: Ohmeda 2300 FinapresO Blood Pressure Monitor, Ohmeda Medical, Englewood, CO 801 12-58IO, K822055 Ohmeda 2350 FinapresB Blood Pressure Monitor, Ohmeda Medical, Englewood, CO 80 1 12-58IO, K880572 Task Force Monitor 3040,… | 1982 |
| * | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure MonitorSummary page 2…lood Pressure Monitor, Ohmeda Medical, Englewood, CO 801 12-58IO, K822055 Ohmeda 2350 FinapresB Blood Pressure Monitor, Ohmeda Medical, Englewood, CO 80 1 12-58IO, K880572 Task Force Monitor 3040, CNSystems Medizintechnik GMBH, Europe, AU, KO1 4063 The Finometer and Finapres are substantially eq… | 1988 |
| * | K014063 | Task Force Monitor 3040 | 2002 |
What descends from it? (81)
See all 813 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 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, K072049 (Bmeye B.V., 2007) has gone furthest, with 78 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 Finometer is intended to be used when there is a need for a noninvasive hemodynamic monitor. The Finometer provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow as well as in various hemodynamic parameters derived from these pressure and flow signals. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments…
Read the full statement (235 words)
The Finometer is intended to be used when there is a need for a noninvasive hemodynamic monitor. The Finometer provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow as well as in various hemodynamic parameters derived from these pressure and flow signals. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.
The noninvasively blood pressure waveform is measured by using the Finapres method of PeiiWesseling. Hemodynamic parameters include cardiac output and total peripheral resistance based on the Modelflow method of Wesseling.
The Finometer is intended to be installed and operated by a qualified physician or operator Pressure measurements are validated for subjects above 18 years of age. The only mode of measuring blood pressure accurately is when the device is used with the return-to-flow method of calibration, if the pressure data are t a comply with the recommendations of the AAMI SPlO standard.
Modelflow built-in calibration is usehl from 18 years on. Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution.
The physiological parameters provided by the device have clinical significance only if determined by a physician and should not be used as the sole means for a patient's diagnosis.
The data provided by the device can be hrther processed by the included PC-based BeatScope software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023723: Finometer Noninvasive Hemodynamic Monitor, Model 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023723
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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