# K202464: Vital Sign Monitoring Sensor (Model :XK300)

- Pathway: 510(k) (Traditional)
- Applicant: Xandar Kardian, Inc.
- Decided: Apr 26, 2021 after 242 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K830295 (1983). 18 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082626: PAM 3000, Wireless 2000 RF & Uwb Technologies, Ltd. (2009) Summary page 4.

## Most influential descendants
- K223163: Sleepiz One+ (2023), 3 descendants of its own
- K234003: The Circadia C200 System (2024), 2 descendants of its own
- K252676: The Circadia C300 System (C300) (2026), 1 descendant of its own
- K251364: Sleepiz One+ (2.5) (2025), 1 descendant of its own
- K212143: Neteera 130H/131H Vital Sign Monitoring Sensor (2022), 1 descendant of its own

## Indications for use
The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in detection area of within 7 meters. The XK30 also monitors the length of continuous patient motion or absence of patient motion.

Source page: https://510kreport.com/device/K202464
Methodology: https://510kreport.com/methodology