510(k) · Cleared
ClearedCareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs 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 Mar 18, 2016 as substantially equivalent to K072049 (Bmeye B.V., 2007) after a 288-day review. Its family tree reaches back 4 generations to 1988. 16 later devices descend from it.
- Decided
- Mar 18, 2016
- Review
- 288 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K880572 (1988). 6 ancestors in all, the oldest K822055 (1982). 16 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK880572 Ohmeda 2350 Finapres (R) Blood Pressure MonitorOhmeda Medical · 1988
- 3 generations backK014063 Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002 · Recalled
- 2 generations backK023723 Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003
- 1 generation backK072049 Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor…Bmeye B.V. · 2007
- This deviceK151499 CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2016
- Descendant · cites it directly · 15 of its ownK163255 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker…Caretaker Medical, LLC · 2017
- Descendant · 2 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 3 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC · 2017 · cites it directly15descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 2 generations on12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 3 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 4 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K880572 | Ohmeda 2350 Finapres (R) Blood Pressure Monitor | Ohmeda Medical | 1988 | — |
| −3 | K014063 | Task Force Monitor 3040 | Cnsystems Medizintechnik GmbH | 2002 | 1 |
| −2 | 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 | — |
| 0 (this device) | K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless… | Caretaker Medical, LLC | 2016 | — |
| +1 | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless… | Caretaker Medical, LLC | 2017 | — |
| +2 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +3 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +4 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +3 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Summary page 4…CFR 870.1130, Product Code: DXN –System, Measurement, Blood‐Pressure, Non‐Invasive Device Class: II 5) Predicate Device: Nexfin HD (K072049) 6) Device Description: _CareTaker is a cardiovascular monitoring device that non‐ invasively measures continuous blood… | 2007 |
What descends from it? (16)
See all 162 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 28 years and passes through 5 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K163255 (Caretaker Medical, LLC, 2017) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K072049.
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. 2016, 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”) and heart rate (“HR”), 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 sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151499: CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151499
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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