CAW — Generator, Oxygen, Portable Class II

FDA Device Classification

Classification Details

Product Code
CAW
Device Class
Class II
Regulation Number
868.5440
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251534foshan kycare medical equipment coOxygen Concentrator (J10A)December 29, 2025
K251764qingdao kingon medical science and technology coOxygen Concentrator-P2-O5EDecember 22, 2025
K252616shenzhen homed medical device coPortable oxygen concentrator (JLO-190P)December 22, 2025
K252268shenzhen harveymed technology coV series portable oxygen concentrator (V5, V5C, V6, V6C)December 16, 2025
K250805devilbiss healthcareDeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)December 9, 2025
K251607foshan kycare medical equipment coOxygen Concentrator (J5A)November 21, 2025
K243833longfian scitech coPortable oxygen concentrator (JAY-1000P)September 29, 2025
K250625nanjing yinuoji medical technology coPortable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1);August 27, 2025
K251130jiangsu jumao x-care medical equipment coPortable Oxygen Concentrator (JM-P50A)August 21, 2025
K250671caireFreeStyle Comfort (AS200 / FreeStyle Comfort)July 11, 2025
K242736jiangsu yuyue medical equipment and supply coPortable Oxygen Concentrator (Spirit-3)June 5, 2025
K242718qingdao kingon medical science and technology coPortable Oxygen Concentrator (P2-TOC)February 28, 2025
K240561molecular productsRugged Oxygen Generator (ROG) (RO01-00001)December 6, 2024
K240840foshan care medical technology coOxygen Concentrator (ZY-10AB/115)December 6, 2024
K230969jiangsu jumao x-care medical equipment coOxygen ConcentratorNovember 9, 2023
K230702qingdao kingon medical science and technology coPortable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)October 18, 2023
K223740jiangsu konsung bio-medical science and technology coOxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)October 5, 2023
K222920zhengzhou olive electronic technology coOxygen concentratorJuly 20, 2023
K230052inogenInogen Rove 6June 30, 2023
K223379qingdao kingon medical science and technology coPortable Oxygen Concentrator (Model: P2-E7, P2-E)June 22, 2023