510(k) · Cleared
ClearedArteVu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Ring Technologies, Inc. Taiwan Branch · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 30, 2025 as substantially equivalent to K163255 (Caretaker Medical, LLC, 2017) after a 216-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Jul 30, 2025
- Review
- 216 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K962603 (1997). 34 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 2 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 1 generation backK163255 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2017
- This deviceK244007 ArteVuCardio Ring Technologies, Inc. Taiwan Branch · 2025
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 5 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 4 generations backK113054 EquivitalHidalgo Limited · 2012
- 3 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 2 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 1 generation backK163255 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2017
- This deviceK244007 ArteVuCardio Ring Technologies, Inc. Taiwan Branch · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −5 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −4 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −3 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −2 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| −1 | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless… | Caretaker Medical, LLC | 2017 | — |
| 0 (this device) | K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2016 | 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.
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? (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 |
|---|---|---|---|
| * | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Summary page 5…870.1130 Product Code(s) DXN | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K163255 CareTaker4 Physiological Monitor DXN Device Description Summary 21 CFR 807.92(a)(4) ArteVu is an automatic, continuous, and non-… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 34 ancestors have a recall of any class.
- 2 other devices also cite its predicate K163255.
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. 2025, 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?
ArteVu is intended to noninvasively and continuously measure a patient’s blood pressure and pulse rate, which are derived from the pulse pressure waveform using the scientific method of pulse waveform decomposition, for use on adult patients aged between 50 and 86 years who are resting in a supine or similarly reclined position.
ArteVu is calibrated using an ISO 81060-2 compliant sphygmomanometer. All parameters derived by ArteVu are shown on a compatible remote display monitor (RDDS) via wired transmission. The device is intended for use by clinicians or other properly trained medical personnel in professional healthcare facilities.
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/K244007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244007: ArteVu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244007
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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