510(k) · Cleared
ClearedCNAP Monitor
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 Sep 11, 2019 as substantially equivalent to K082599 (Cnsystem Medizintechnik AG, 2008) and 2 other predicates after a 266-day review. Its family tree reaches back 11 generations to 2000. 1 of the 40 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 11, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K000126 (2000). 38 ancestors in all, the oldest K822055 (1982). 1 later device descends from it, 1 citing it directly. 1 of the 40 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 7 generations between
- 3 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 2 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 1 generation backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK183521 CNAP MonitorCnsystems Medizintechnik GmbH · 2019
- Descendant · cites it directly · 0 of its ownK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
Show all 11 generations
- Root · 11 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 10 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 9 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 8 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
- 7 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- 6 generations backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- 5 generations backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 4 generations backK101123 Nexfin Model 2Bmeye B.V. · 2010
- 3 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 2 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 1 generation backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK183521 CNAP MonitorCnsystems Medizintechnik GmbH · 2019
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…direct predicate · 2016
Most influential descendants
Showing 1 of 1 · See all- K223332Task Force CORECnsystems Medizintechnik GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −10 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −9 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −8 | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | 1 |
| −7 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| −6 | K061204 | Masimo Set Radical 7 Pulse CO-Oximeter | Masimo Corporation | 2006 | — |
| −5 | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | 1 |
| −4 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| −3 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
| −2 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| −1 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| 0 (this device) | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | — |
| +1 | 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 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATSummary page 5…® 510(k) Submission CNAP Monitor 500 HD 5.2 Device information 5.2.1 Primary Predicate Device - CNAP® Monitor 500i, 500at Clearance number: K082599 Manufacturer: CNSystems Medizintechnik AG Reininghausstrasse 13, A-8020 Graz, Austria This predic… | 2008 |
| * | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Summary page 5…cate Device - EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System, EV1000 Clinical Platform Clearance number: K160552 Manufacturer: Edwards Lifesciences, LLC One Edwards Way, Irvine, California 92614 This predicat… | 2016 |
| * | K172259 | PulsioFlex Monitoring SystemSummary page 5…d cause and hazard and found to be not affected. See Section 10 and 11 for Details. 5.2.3 Third Predicate Device – PulsioFlex Monitoring System Clearance number: K172259 Manufacturer: PULSION Medical Systems SE; Maquet Cardiovascular 45 Barbour… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223332 | Task Force CORE | 2023 | 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 8 of the 38 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K223332 (Cnsystems Medizintechnik GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082599.
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. 2019, 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 CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals.
The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters. Alarms are generated for blood pressure parameters and pulse rate.
The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183521: CNAP Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183521
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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