Cleared Traditional

Oxygen Concentrator, Model JAY-5AW

K213210 · Longfian Scitech Co., Ltd. · Anesthesiology
Dec 2022
Decision
435d
Days
Class 2
Risk

About This 510(k) Submission

K213210 is an FDA 510(k) clearance for the Oxygen Concentrator, Model JAY-5AW, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Longfian Scitech Co., Ltd. (Baoding, CN). The FDA issued a Cleared decision on December 8, 2022, 435 days after receiving the submission on September 29, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K213210 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date December 08, 2022
Days to Decision 435 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
Oxygen Concentrator-P2-O5E
K251764 · Qingdao Kingon Medical Science and Technology 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