510(k) · Cleared
ClearedCareTaker Monitor App
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 30, 2022 as substantially equivalent to K072049 (Bmeye B.V., 2007) and 2 other predicates after a 127-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 30, 2022
- Review
- 127 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K963725 (1997). 28 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 3 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 2 generations backK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
- 1 generation backK123130 Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013
- This deviceK213699 CareTaker Monitor AppCaretaker Medical, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −3 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −2 | K050620 | Readmyheart, Model RMH3.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K123130 | Answatch Wrist Monitor Model TS-0411 | Taiwan Scientific Corporation | 2013 | — |
| 0 (this device) | K213699 | CareTaker Monitor App | Caretaker Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Summary page 4…21 CFR 870.1130 21 CFR 870.2910 Device Class: II 5) Predicate Devices: Nexfin_HD (for cardiac output/stroke volume, K072049), Finapres Portapres model 2 (for left ventricular ejection time, K023338), and ANSWatch (for heart rate va… | 2007 |
| * | K023338 | Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Summary page 4…lass: II 5) Predicate Devices: Nexfin_HD (for cardiac output/stroke volume, K072049), Finapres Portapres model 2 (for left ventricular ejection time, K023338), and ANSWatch (for heart rate variability measures, K123130). 6) Device Description: The Caretaker Advanced… | 2003 |
| * | K123130 | Answatch Wrist Monitor Model TS-0411Summary page 4…roke volume, K072049), Finapres Portapres model 2 (for left ventricular ejection time, K023338), and ANSWatch (for heart rate variability measures, K123130). 6) Device Description: The Caretaker Advanced Hemodynamic Parameters is a firmware upgrade that runs on the… | 2013 |
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 25 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 28 ancestors have a recall of any class.
- 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. 2022, 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 Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements, the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213699: CareTaker Monitor App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213699
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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