# K190399: Beddr 200 System

- Pathway: 510(k) (Traditional)
- Applicant: Hancock Medical, Inc.
- Decided: Aug 5, 2019 after 167 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Beddr 200 System is a reusable forehead reflectance sensor indicated for use in measuring and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and/or data collection and recording of patients during no motion conditions, who are well perfused, in a home or healthcare environment.

Source page: https://510kreport.com/device/K190399
Methodology: https://510kreport.com/methodology