CONTEC Oxygen Concentrator
FDA 510(k) K180837 · Contec Medical System Co., Ltd.
510(k) numberK180837
Submission
- Device name
- CONTEC Oxygen Concentrator
- Applicant
- Contec Medical System Co., Ltd.
Qinhuangdao, CN - Received
- March 30, 2018
- Decision date
- January 10, 2019
- 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 |
|---|---|---|
| K131900 | Contec ElectrocardiographDPS · Traditional | 03/05/2014SE |
| K101273 | Dynamic ECG System Model TLC5000MLO · Traditional | 09/30/2011SE |
| K110156 | Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,DXN · Traditional | 07/27/2011SE |
| K101692 | Patient MonitorMHX · Traditional | 06/28/2011SE |
| K110774 | Electronic SphygmomanometerDXN · Traditional | 05/13/2011SE |
| K101127 | Patient Monitor, Model PM50MWI · Traditional | 06/11/2010SE |
| K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80ADPS · Traditional | 08/25/2009SE |
| K090671 | Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DDQA · Traditional | 06/11/2009SE |
| K082480 | Contec Pocket Fetal DopplerKNG · Traditional | 02/25/2009SE |
| K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLDQA · Special | 11/10/2008SE |
Questions and answers
When was CONTEC Oxygen Concentrator cleared by the FDA?
CONTEC Oxygen Concentrator (K180837) received a 510(k) decision of Substantially Equivalent on January 10, 2019, 286 days after the submission was received.
What is the product code of K180837?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.