Oxygen Concentrator - KSN-5

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223740

by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.

Identifiers

510(k) Number: K223740 FDA 510(k)
FDA Product Code: CAW FDA 510(k)
Models / Variants: Model: KSW-5 FDA 510(k)EUDAMED
KSN-5 FDA 510(k)EUDAMED
KSOC-5 FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.5440 FDA 510(k)
Regulation Number: 868.5440 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

An Oxygen Concentrator is a device that generates oxygen from ambient air for therapeutic use. This model is a portable oxygen generator classified under device class 2 and product code CAW.

It is supplied as a reusable device for use in medical settings, with authorization under FDA 510(k) (K223740), IVDD, MDD, and MDR. The device is intended for use in environments requiring supplemental oxygen delivery, as indicated by its classification and regulatory submissions.

Frequently asked questions

What models are included in this Oxygen Concentrator designation?

The designation includes the specific models KSW-5, KSN-5, and KSOC-5, as explicitly stated in the device name and specifications. These model numbers must be retained exactly to ensure accurate identification.

Is this Oxygen Concentrator portable and what is its device class?

Yes, the device is described as a portable oxygen generator in the openfda field, and it is classified as device class 2, indicating it is a moderate-risk medical device requiring special controls.

What regulatory authorizations apply to this Oxygen Concentrator?

The device has authorizations listed as FDA_510K, IVDD, MDD, and MDR, indicating compliance with U.S. FDA 510(k) requirements and relevant European regulatory frameworks for medical devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

IVDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	IVDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K223740	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.
FDA Applicant: Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.

Sources (2)

FDA 510(k) K223740 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 18, 2026