Cleared Traditional

Oxygen Concentrator-P2-O5E

K251764 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Anesthesiology
Dec 2025
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K251764 is an FDA 510(k) clearance for the Oxygen Concentrator-P2-O5E, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Qingdao Kingon Medical Science and Technology Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on December 22, 2025, 196 days after receiving the submission on June 9, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K251764 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2025
Decision Date December 22, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

Similar Devices — CAW Generator, Oxygen, Portable

All 282
Oxygen Concentrator (J10A)
K251534 · Foshan Kycare Medical Equipment Co., Ltd. · Dec 2025
Portable oxygen concentrator (JLO-190P)
K252616 · Shenzhen Homed Medical Device Co., Ltd. · Dec 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · Shenzhen Harveymed Technology Co., Ltd. · Dec 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
K250805 · Devilbiss Healthcare, LLC · Dec 2025
Oxygen Concentrator (J5A)
K251607 · Foshan Kycare Medical Equipment Co., Ltd. · Nov 2025
Portable oxygen concentrator (JAY-1000P)
K243833 · Longfian Scitech Co., Ltd. · Sep 2025