510(k) K251764
- Device
- Oxygen Concentrator-P2-O5E
- Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd.
- 510(k) number
- K251764
- Product code
- CAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-22
- Date received
- 2025-06-09
- Regulation
- 868.5440
- Classification name
- Generator, Oxygen, Portable
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zhang Benrong
- Address
- Rm. 301-302, #15 Hancheng Rd., Qingdao Free Trade Zone 24th Bldg., # 252 Yanhe Rd., Huangdao Qingdao CN 266510 266510
FDA Registration Numbers#
- 3014810929
- 3042507287
- 3003637574
- 3001400310
- 3015772781
- 3011767915
- 3005587132
- 3027241818
- 3016859940
- 3009096682
- 3018783526
- 3006240053
- 3005873568
- 1319044
- 3006534178
- 3017520736
- 9710644
- 1220477
- 3003803075
- 3017684630
- 3011120183
- 3002807637
- 3011895992
- 3010440667
- 3004112621
- 3003207908
- 3007344957
- 3009128734
- 9611451
- 2515872
- 3016809216
- 3033859527
- 3013000203
- 1039215
- 2183615
- 3004972304
- 3033814505
- 3011249646
- 3023272766
- 3043648593
- 2032532
- 3012316249
- 3009550619
- 3017825461
- 3013095415
- 3029227324
- 2028807
- 2518422
- 3037045878
- 3023245116
- 3007220521
- 3043460907
- 3008220943
- 3004672275
- 2523148
- 3005569927
- 3006991053
- 3011191255
- 1000604079
- 3000126629
- 1924066
- 3004964590
- 3014661487
- 3015142815
- 3008507279
- 3032013079
- 3033526676
- 3005803793
- 3008841036
- 3007307467
- 3009683397
- 2085602
- 3025889185
- 3011205710
- 3020476987
- 3007573469
- 3010287621
- 3010317211
- 1419185
Source Documents#
Other 510(k) Records For Product Code CAW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | 2026-04-23 |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026-03-26 |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025-12-16 |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | 2025-12-09 |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-11-21 |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | 2025-09-29 |
| K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025-08-27 |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2025-08-21 |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | 2025-07-11 |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 |
| K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | 2024-12-06 |
| K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. | 2024-12-06 |