510(k) clearance

Portable Oxygen Concentrator (OX-1A-E, OX-1B)

FDA 510(k) source

510(k) number

K254289

Applicant

Oxytek Medical Technology Co., Ltd.

Decision date

Sep 23, 2026

Date received

Dec 31, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

CAW

Device type

Generator, Oxygen, Portable

Device class

Class II

Regulation

21 CFR 868.5440

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

Chencun Town, Shunde District, Foshan, CN