Chad Total O2 Delivery System
FDA 510(k) K971889 · Chad Therapeutics, Inc.
510(k) numberK971889
Submission
- Device name
- Chad Total O2 Delivery System
- Applicant
- Chad Therapeutics, Inc.
Chatsworth, CA, US - Received
- May 21, 1997
- Decision date
- November 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
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| 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 |
|---|---|---|
| K081176 | FlochannelMNR · Traditional | 07/28/2008SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | 05/07/2007SE |
| K042142 | Chad Therapeutics Lotus, Models OM-700 and OM-700SNFB · Special | 09/20/2004SE |
| K033364 | Chad Therapeutics SageNFB · Traditional | 05/11/2004SE |
| K020475 | Chad Therapeutics Oxypenumatic Cypress Model 511NFB · Traditional | 07/05/2002SE |
| K013472 | Total O2CAW · Traditional | 11/28/2001SE |
| K010389 | Chad Therapeutics Oxymatic Model 401 and Oxymatic Model 411NFB · Special | 03/23/2001SE |
| K003455 | Modification to Chad Therapeutics Oxymatic Model 401NFB · Special | 12/06/2000SE |
| K000890 | Chad Therapeutics Oxymatic Model 401NFB · Traditional | 06/16/2000SE |
| K884562 | OXYMATIC-24NFB · Traditional | 01/09/1989SE |
Questions and answers
When was Chad Total O2 Delivery System cleared by the FDA?
Chad Total O2 Delivery System (K971889) received a 510(k) decision of Substantially Equivalent on November 17, 1997, 180 days after the submission was received.
What is the product code of K971889?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.