510(k) · Cleared
ClearedNon-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cnsystem Medizintechnik AG · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 17, 2008 as substantially equivalent to K014063 (Cnsystems Medizintechnik GmbH, 2002) and 1 other predicate after a 39-day review. Its family tree reaches back 6 generations to 1997. 25 later devices descend from it.
- Decided
- Oct 17, 2008
- Review
- 39 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962603 (1997). 13 ancestors in all, the oldest K880572 (1988). 25 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 1 generation backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- This deviceK082599 Non-Invasive Continuous Blood Pressure Monitoring System Cnap…Cnsystem Medizintechnik AG · 2008
- Descendant · cites it directly · 19 of its ownK130709 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013
- Descendant · 2 generations on · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- Descendant · 3 generations on · 6 of its ownK150361 ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K130709Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013 · cites it directly19descendants
- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 2 generations on17descendants
- K150992Vios Monitoring SystemVios Medical, Inc. · 2015 · 3 generations on7descendants
- K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 3 generations on6descendants
- K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −1 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| 0 (this device) | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I… | Cnsystem Medizintechnik AG | 2008 | — |
| +1 | K130709 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2013 | — |
| +2 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +3 | K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015 | — |
| +3 | K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| +4 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
Planning a device in DXN? 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 |
|---|---|---|---|
| * | K014063 | Task Force Monitor 3040Summary page 1…asive, DXN The CNAP Monitor 500 is substantially equivalent to the Task Force Predicate: Monitor 3040 (K014063) and ZOLt. M-Series N[BP Option (k032363 The CNAP<'… | 2002 |
| * | K032363 | Zoll M Series Nibp OptionSummary page 1…ntially equivalent to the Task Force Predicate: Monitor 3040 (K014063) and ZOLt. M-Series N[BP Option (k032363 The CNAP<' Monitor 500 is a device for continuous non-invasive… | 2003 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K130709 (Sotera Wireless, Inc., 2013) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K014063.
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. 2008, 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 is intended for the monitoring of non-invasive continuous blood pressure and pulse rate in hospitals, clinical institutions, medical practices and outpatient settings. The device displays the blood pressure waveform and generates trends, beat-to-beat numerics and alarms for the parameters blood pressure and pulse rate. The CNAP Monitor 500 is to be used for adults and pediatric patients from the age of 4 year and is to be operated by physicians and other medical professional staff.
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/K082599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082599: Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082599
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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