CAW — Generator, Oxygen, Portable Class II
FDA product code CAW covers "Generator, Oxygen, Portable", a Class II medical device regulated under 21 CFR 868.5440. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CAW
- Device Class
- Class II
- Regulation Number
- 868.5440
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252399 | honsun (nantong) co | Portable Oxygen Concentrator | June 17, 2026 |
| K252965 | oxytek medical technology co | Oxygen Concentrator (OX-5A, OX-5C) | May 29, 2026 |
| K252407 | mv life | OxyGo Portable Oxygen Concentrator (1400-7000) | April 23, 2026 |
| K253549 | devilbiss healthcare | DeVilbiss 5 Liter Oxygen Concentrator (555) | March 26, 2026 |
| K251534 | foshan kycare medical equipment co | Oxygen Concentrator (J10A) | December 29, 2025 |
| K252616 | shenzhen homed medical device co | Portable oxygen concentrator (JLO-190P) | December 22, 2025 |
| K251764 | qingdao kingon medical science and technology co | Oxygen Concentrator-P2-O5E | December 22, 2025 |
| K252268 | shenzhen harveymed technology co | V series portable oxygen concentrator (V5, V5C, V6, V6C) | December 16, 2025 |
| K250805 | devilbiss healthcare | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | December 9, 2025 |
| K251607 | foshan kycare medical equipment co | Oxygen Concentrator (J5A) | November 21, 2025 |
| K243833 | longfian scitech co | Portable oxygen concentrator (JAY-1000P) | September 29, 2025 |
| K250625 | nanjing yinuoji medical technology co | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); | August 27, 2025 |
| K251130 | jiangsu jumao x-care medical equipment co | Portable Oxygen Concentrator (JM-P50A) | August 21, 2025 |
| K250671 | caire | FreeStyle Comfort (AS200 / FreeStyle Comfort) | July 11, 2025 |
| K242736 | jiangsu yuyue medical equipment and supply co | Portable Oxygen Concentrator (Spirit-3) | June 5, 2025 |
| K242718 | qingdao kingon medical science and technology co | Portable Oxygen Concentrator (P2-TOC) | February 28, 2025 |
| K240840 | foshan care medical technology co | Oxygen Concentrator (ZY-10AB/115) | December 6, 2024 |
| K240561 | molecular products | Rugged Oxygen Generator (ROG) (RO01-00001) | December 6, 2024 |
| K230969 | jiangsu jumao x-care medical equipment co | Oxygen Concentrator | November 9, 2023 |
| K230702 | qingdao kingon medical science and technology co | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | October 18, 2023 |