# K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Caretaker Medical, LLC
- Decided: Apr 21, 2017 after 151 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 33 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151499: CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor, Caretaker Medical, LLC (2016) Summary page 4.
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics, Bmeye B.V. (2007) Summary page 4.
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch, Vitalconnect, Inc. (2015) Summary page 4.

## Most influential descendants
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 descendants of its own
- K250415: G0 Blood Pressure Monitoring System (G0) (2025), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K163255
Methodology: https://510kreport.com/methodology