510(k) · Cleared
ClearedCareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caretaker Medical, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 21, 2017 as substantially equivalent to K151499 (Caretaker Medical, LLC, 2016) and 2 other predicates after a 151-day review. Its family tree reaches back 9 generations to 1997. 15 later devices descend from it.
- Decided
- Apr 21, 2017
- Review
- 151 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962603 (1997). 33 ancestors in all, the oldest K822055 (1982). 15 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK113054 EquivitalHidalgo Limited · 2012
- 2 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 1 generation backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- This deviceK163255 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2017
- Descendant · cites it directly · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK250415 G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 3 generations backK113054 EquivitalHidalgo Limited · 2012
- 2 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 1 generation backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- This deviceK163255 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · cites it directly12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 2 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 3 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 2 generations on2descendants
- K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −3 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −1 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| 0 (this device) | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless… | Caretaker Medical, LLC | 2017 | — |
| +1 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +2 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +3 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +2 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
| +2 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs…Summary page 4…Product Code: DXN –System, Measurement, Blood-Pressure, Non-Invasive Device Class: II 5) Predicate Devices: CareTaker (K151499), Nexfin HD (K072049), HealthPatch MD (K152139) 6) Device Description: CareTaker is a cardiovascular moni… | 2016 |
| * | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Summary page 4…t Code: DXN –System, Measurement, Blood-Pressure, Non-Invasive Device Class: II 5) Predicate Devices: CareTaker (K151499), Nexfin HD (K072049), HealthPatch MD (K152139) 6) Device Description: CareTaker is a cardiovascular monitoring device that no… | 2007 |
| * | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatchSummary page 4…-Pressure, Non-Invasive Device Class: II 5) Predicate Devices: CareTaker (K151499), Nexfin HD (K072049), HealthPatch MD (K152139) 6) Device Description: CareTaker is a cardiovascular monitoring device that non- invasively measures con… | 2015 |
What descends from it? (15)
See all 153 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 20 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 33 ancestors have a recall of any class.
- Of its descendants, K190792 (Biobeat Technologies, Ltd., 2019) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K151499.
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. 2017, 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?
CareTaker is intended to noninvasively and continuously measure a patient’s blood pressure (“BP”), heart rate (“HR™”), and respiration rate (“RSP”), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis (“PDA”) for use on adult patients at rest. CareTaker is calibrated using a manual method or any AAMI 81060 compliant BP device, or is automatically calibrated using its self-calibration mode. All…
Read the full statement (113 words)
CareTaker is intended to noninvasively and continuously measure a patient’s blood pressure (“BP”), heart rate (“HR™”), and respiration rate (“RSP”), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis (“PDA”) for use on adult patients at rest. CareTaker is calibrated using a manual method or any AAMI 81060 compliant BP device, or is automatically calibrated using its self-calibration mode. All parameters derived by CareTaker are reported to an integrated LCD screen and optionally to a remote display monitor (RDDS) via standard radio transmission protocols. The device is intended for use by clinicians or other properly trained medical personnel and does not provide any physiological alarm functions.
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/K163255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163255
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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