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Vital Sign Monitoring Sensor (Model :XK300)

by Xandar Kardian, Inc.

510(k) K202464

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202464 Date26 Apr 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vital Sign Monitoring Sensor (Model :XK300) is a class II medical device that provides non-invasive monitoring of motion, resting heart rate, and respiratory rate using radar technology. It is designed for contact-free monitoring with wall- and ceiling-mounted devices, eliminating the need for wearables or physical contact.

This device is supplied for use in various settings and offers continuous, autonomous vital sign monitoring while ensuring patient comfort and privacy. It is FDA 510(k) cleared and has been cleared for monitoring motion, resting heart rate, respiratory rate, and presence detection of a patient using radar technology.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What vital signs does the XK300 sensor monitor without contact?

    The XK300 uses radar to detect motion, resting heart rate and respiratory rate. By emitting low‑power radio waves and interpreting the reflected signals, it can calculate these parameters without any wearable or skin‑contact device, preserving patient comfort and privacy.

  • How is the XK300 supplied and installed in a clinical setting?

    The device is delivered as a ready‑to‑mount unit intended for wall or ceiling installation. It integrates with existing monitoring infrastructure and operates autonomously, so no additional consumables or accessories are required for its basic function.

  • Is the XK300 a single‑use or reusable device, and does it require sterilization?

    The XK300 is a reusable, electronic sensor designed for repeated use. Because it monitors patients without physical contact, there is no need for sterilization between patients, simplifying workflow and reducing consumable costs.

  • What regulatory pathway was used for the XK300 and what does that imply for its clinical use?

    The XK300 received FDA 510(k) clearance through the traditional pathway, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance permits its use in the United States for the indicated monitoring functions under the conditions specified in the clearance.