Cleared Traditional

V series portable oxygen concentrator (V5, V5C, V6, V6C)

K252268 · Shenzhen Harveymed Technology Co., Ltd. · Anesthesiology

Dec 2025

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K252268 is an FDA 510(k) clearance for the V series portable oxygen concentrator (V5, V5C, V6, V6C), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Shenzhen Harveymed Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 16, 2025, 148 days after receiving the submission on July 21, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number	K252268 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2025
Decision Date	December 16, 2025
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF