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United States FDA 510(k) clearance K251607Substantially Equivalent

Oxygen Concentrator (J5A)

United StatesClass 2Foshan Kycare Medical Equipment Co., Ltd.Cleared Nov 21, 2025
Verified
Clearance details
K-Number
K251607
View FDA 510(k) Summary PDF View on FDA Database
Note: PDF may not be available for all submissions
Product Code
CAW
View Product Code Classification
Device Class
Class 2
Clearance Type
Traditional
Regulation Number
868.5440
View CFR Regulation
Applicant information
Applicant
Foshan Kycare Medical Equipment Co., Ltd.
Contact
Leona Zhou
Location
Rm. 401, Bldg. 29, Liandong Yougu Park, # 3
Dongsan District, Jiansha Rd., Danzao Town, Nanhai District
Foshan 528000
CN
Medical classification
Medical Specialty
Anesthesiology
Advisory Committee
AN
Dates and decision
Date Received
May 27, 2025
Decision Date
Nov 21, 2025
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for Oxygen Concentrator (J5A) in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K251607 and submitted by Foshan Kycare Medical Equipment Co., Ltd.. The clearance decision was Substantially Equivalent on Nov 21, 2025.

This page provides complete clearance details including product code CAW, medical specialty classification (Anesthesiology), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.