Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
FDA 510(k) K213825 · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
510(k) numberK213825
Submission
- Device name
- Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Danyang, CN - Received
- December 8, 2021
- Decision date
- April 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
Other 510(k)s with product code CAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | BMC Medical Co., Ltd. | 08/14/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | Honsun (Nantong) Co., Ltd. | 06/17/2026SE |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional | Mv Life, LLC | 04/23/2026SE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7)IOR · Traditional | 08/06/2026SE |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR)DXN · Traditional | 03/05/2026SE |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR)DXN · Traditional | 02/23/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | 02/17/2026SE |
| K242736 | Portable Oxygen Concentrator (Spirit-3)CAW · Traditional | 06/05/2025SE |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional | 05/22/2025SE |
| K221372 | YUWELL Electronic Blood Pressure MonitorDXN · Traditional | 10/17/2022SE |
| K212385 | YUWELL Finger Pulse OximeterDQA · Traditional | 08/16/2022SE |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200FLL · Traditional | 05/20/2021SE |
| K201864 | YUWELL Infrared ThermometerFLL · Traditional | 12/07/2020SE |
Questions and answers
When was Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A cleared by the FDA?
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (K213825) received a 510(k) decision of Substantially Equivalent on April 28, 2023, 506 days after the submission was received.
What is the product code of K213825?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.