# K151499: CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Caretaker Medical, LLC
- Decided: Mar 18, 2016 after 288 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: 4 generations back to K880572 (1988). 6 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics, Bmeye B.V. (2007) Summary page 4.

## Most influential descendants
- K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor (2017), 15 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K151499
Methodology: https://510kreport.com/methodology