# K212143: Neteera 130H/131H Vital Sign Monitoring Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neteera Technologies, Ltd.
- Decided: Sep 28, 2022 after 446 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: 5 generations back to K830295 (1983). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202464: Vital Sign Monitoring Sensor (Model :XK300), Xandar Kardian, Inc. (2021) Summary page 4.

## Most influential descendants
- K231733: Neteera 130H-Plus Vital Sign Monitoring Sensor (2024), 0 descendants of its own

## Indications for use
The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring). The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).

Source page: https://510kreport.com/device/K212143
Methodology: https://510kreport.com/methodology