# K183556: oCare Wrist Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Biophotonic Corporation
- Decided: Feb 15, 2019 after 57 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
Longest line of descent: 5 generations back to K001085 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163382: Oxitone 1000, Oxitone Medical, Ltd. (2017) Summary page 4.

## Indications for use
The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospitals, hospital-type facilities, and home environments.

Source page: https://510kreport.com/device/K183556
Methodology: https://510kreport.com/methodology