Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAW — Predicate Candidate Screening
287 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
316 days90th percentile
287clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | 2026-06-17 | 321 | 0 |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | 2026-05-29 | 254 | 0 |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | 2026-04-23 | 266 | 0 |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026-03-26 | 132 | 0 |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 | 224 | 0 |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-12-22 | 196 | 0 |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 | 125 | 0 |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025-12-16 | 148 | 0 |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | 2025-12-09 | 267 | 0 |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-11-21 | 178 | 0 |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | 2025-09-29 | 290 | 0 |
| K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen co | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025-08-27 | 177 | 0 |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2025-08-21 | 132 | 0 |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | 2025-07-11 | 128 | 0 |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 | 267 | 0 |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 | 171 | 0 |
| K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. | 2024-12-06 | 281 | 0 |
| K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | 2024-12-06 | 254 | 0 |
| K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023-11-09 | 218 | 1 |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-10-18 | 218 | 0 |
| K223740 | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | 2023-10-05 | 295 | 0 |
| K222920 | Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. | 2023-07-20 | 297 | 0 |
| K230052 | Inogen Rove 6 | Inogen, Inc. | 2023-06-30 | 175 | 0 |
| K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-06-22 | 227 | 0 |
| K211056 | Oxus Sieve Beds | Oxus, Inc. | 2023-05-31 | 782 | 0 |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2023-04-28 | 506 | 0 |
| K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen | 2022-12-09 | 147 | 0 |
| K213210 | Oxygen Concentrator, Model JAY-5AW | Longfian Scitech Co., Ltd. | 2022-12-08 | 435 | 1 |
| K210371 | Portable Oxygen Concentrator, model: P2-E6 | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2022-06-03 | 480 | 0 |
| K202389 | Oxygen Concentrator | Foshan Mic Medical Technology Co., Ltd. | 2022-04-08 | 595 | 0 |
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator | Invacare Corporation | 2021-04-12 | 164 | 0 |
| K203086 | X-PLO2R | Belluscura, LLC | 2021-03-02 | 140 | 0 |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | Invacare Corporation | 2020-08-06 | 125 | 0 |
| K200496 | Aer X | 3B Medical, Inc. | 2020-07-24 | 147 | 0 |
| K191875 | Owgels Oxygen Concentrator | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020-07-20 | 374 | 0 |
| K192693 | Nuvo Nano Portable Oxygen Concentrator | Nidek Medical Products, Inc. | 2020-05-07 | 224 | 0 |
| K190304 | Kingon P2 Oxygen Concentrator | Qingdao Kingon Medical Science and Technology Co. | 2020-02-29 | 382 | 0 |
| K191159 | Concentrator with Single battery pack, carry bag with should | Invacare Corporation | 2019-08-29 | 120 | 0 |
| K180837 | CONTEC Oxygen Concentrator | Contec Medical System Co., Ltd. | 2019-01-10 | 286 | 0 |
| K182454 | O2 Concepts Oxlife Independence Model 301-0001 | O2 Concepts, LLC | 2018-12-20 | 104 | 0 |
| K172234 | Oxygen Concentrator | Sysmed (China) Co., Ltd. | 2018-06-01 | 311 | 0 |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | Devilbiss Healthcare, LLC | 2018-03-23 | 203 | 1 |
| K162433 | GCE Zen-O Portable Oxygen Concentrator | Oxus, Inc. | 2017-05-24 | 266 | 1 |
| K160630 | Invacare Platinum Mobile Oxygen Concentrator | Invacare Corporation | 2016-09-27 | 204 | 0 |
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | Airsep Corporation | 2015-12-18 | 256 | 0 |
| K141967 | PUREFILL OXYGEN COMPRESSOR | Inovo, Inc. | 2014-11-07 | 109 | 0 |
| K131968 | LONGFIAN OXYGEN CONCENTRATOR | Longfian Scitech Co., Ltd. | 2014-09-05 | 434 | 0 |
| K132489 | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) | Inogen, Inc. | 2014-06-20 | 316 | 0 |
| K132205 | ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM | Inova Labs, Inc. | 2014-06-06 | 325 | 0 |
| K134023 | 2300 SERIES MGO PORTABLE OXYGEN | Ultra Electronics Limited Precision Air & Land SY | 2014-04-25 | 116 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda