FDA Product Code CAW: Generator, Oxygen, Portable
Leading manufacturers include Invacare Corp., Mountain Medical Equipment, Inc. and The John Bunn Co..
288
Total
288
Cleared
144d
Avg days
1976
Since
Growing category -
19 submissions in the last 2 years
vs 10 in the prior period
Review times increasing: avg
211d
recently vs 140d historically
FDA 510(k) Cleared Generator, Oxygen, Portable Devices (Product Code CAW)
288 devices
Cleared
Aug 14, 2026
Portable Oxygen Concentrator (PO1 5B, PO1 6B)
BMC Medical Co., Ltd.
Anesthesiology
205d
Cleared
Jun 17, 2026
Portable Oxygen Concentrator
Honsun (Nantong) Co., Ltd.
Anesthesiology
321d
Cleared
May 29, 2026
Oxygen Concentrator (OX-5A, OX-5C)
Oxytek Medical Technology Co., Ltd.
Anesthesiology
254d
Cleared
Apr 23, 2026
OxyGo Portable Oxygen Concentrator (1400-7000)
Mv Life, LLC
Anesthesiology
266d
Cleared
Mar 26, 2026
DeVilbiss 5 Liter Oxygen Concentrator (555)
Devilbiss Healthcare, LLC
Anesthesiology
132d
Cleared
Dec 29, 2025
Oxygen Concentrator (J10A)
Foshan Kycare Medical Equipment Co., Ltd.
Anesthesiology
224d
Cleared
Dec 22, 2025
Oxygen Concentrator-P2-O5E
Qingdao Kingon Medical Science and Technology Co., Ltd.
Anesthesiology
196d
Cleared
Dec 22, 2025
Portable oxygen concentrator (JLO-190P)
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology
125d
Cleared
Dec 16, 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
Shenzhen Harveymed Technology Co., Ltd.
Anesthesiology
148d
Cleared
Dec 09, 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
Devilbiss Healthcare, LLC
Anesthesiology
267d
Cleared
Nov 21, 2025
Oxygen Concentrator (J5A)
Foshan Kycare Medical Equipment Co., Ltd.
Anesthesiology
178d
Cleared
Sep 29, 2025
Portable oxygen concentrator (JAY-1000P)
Longfian Scitech Co., Ltd.
Anesthesiology
290d
Cleared
Aug 27, 2025
Portable oxygen concentrator (W-R1(MAX))
Nanjing Yinuoji Medical Technology Co., Ltd.
Anesthesiology
177d
Cleared
Aug 21, 2025
Portable Oxygen Concentrator (JM-P50A)
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Anesthesiology
132d
Cleared
Jul 11, 2025
FreeStyle Comfort (AS200 / FreeStyle Comfort)
Caire, Inc.
Anesthesiology
128d
Cleared
Jun 05, 2025
Portable Oxygen Concentrator (Spirit-3)
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Anesthesiology
267d
Cleared
Feb 28, 2025
Portable Oxygen Concentrator (P2-TOC)
Qingdao Kingon Medical Science and Technology Co., Ltd.
Anesthesiology
171d
Cleared
Dec 06, 2024
Rugged Oxygen Generator (ROG) (RO01-00001)
Molecular Products , Ltd.
Anesthesiology
281d
Cleared
Dec 06, 2024
Oxygen Concentrator (ZY-10AB/115)
Foshan Care Medical Technology Co., Ltd.
Anesthesiology
254d
Cleared
Nov 09, 2023
Oxygen Concentrator
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Anesthesiology
218d
Cleared
Oct 18, 2023
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Qingdao Kingon Medical Science and Technology Co., Ltd.
Anesthesiology
218d
Cleared
Oct 05, 2023
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.
Anesthesiology
295d
Cleared
Jul 20, 2023
Oxygen concentrator
Zhengzhou Olive Electronic Technology Co., Ltd.
Anesthesiology
297d
Cleared
Jun 30, 2023
Inogen Rove 6
Inogen, Inc.
Anesthesiology
175d
About Product Code CAW - Regulatory Context
510(k) Submission Activity
288 total 510(k) submissions under product code CAW since 1976, with 288 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 19 submissions in the last 24 months compared to 10 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - CAW Product Code
Recent submissions under CAW have taken an average of 211 days to reach a decision - up from 140 days historically. Manufacturers should account for longer review timelines in current project planning.
CAW devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →