# K231733: Neteera 130H-Plus Vital Sign Monitoring Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neteera Technologies, Ltd.
- Decided: Feb 9, 2024 after 241 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: 6 generations back to K830295 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212143: Neteera 130H/131H Vital Sign Monitoring Sensor, Neteera Technologies, Ltd. (2022) Summary page 4.

## Indications for use
The Neteera 130H-Plus device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring) and inform on bed exit. 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/K231733
Methodology: https://510kreport.com/methodology