FDA product code · Anesthesiology
CAWGenerator, Oxygen, Portable
Product code CAW covers Generator, Oxygen, Portable, a Class II device regulated under 21 CFR 868.5440. FDA has cleared 287 devices in this code, 13 of them in the last 12 months. Median review time across the 287 most recent decisions is 104 days. openFDA lists 44 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5440
- Review panel
- Anesthesiology
- Clearances
- 287
What is happening in CAW right now?
CAW (Generator, Oxygen, Portable) has four findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1815-2026, Z-0481-2026). 7 first-time filers in the last 12 months, including Honsun (Nantong) Co., Ltd. and Oxytek Medical Technology Co., Ltd (K252399, K252965, K252407, K252616, K252268). Clearances are running 88% slower — a median 196 days over the last 12 months against 104 days all-time (elapsed calendar days, not FDA review days) (CAW:review_time:12m). The code is crowded, scoring 95 of 100 — 141 companies hold a clearance here and 13 arrived in the last 12 months (CAW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1815-2026, Z-0481-2026 |
| New entrant | Worth knowing | K252399, K252965, K252407, K252616, K252268 |
| Review time | Context | CAW:review_time:12m |
| Crowding | Context | CAW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in CAW?
FDA has cleared 287 devices under product code CAW since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. |
How long does FDA review take for CAW?
The median FDA review time for CAW is 104 days, measured across the 287 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in CAW?
openFDA lists 44 recall records against product code CAW. A recall record covers one firm's corrective action and may span many device lots.
Z-1815-2026Open, Classified3B Medical, Inc.
Devices which did not meet internal quality specifications were inadvertently distributed.
Z-0481-2026Open, ClassifiedPhilips Respironics, Inc.
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Z-1980-2025Open, ClassifiedOhio Medical Corporation
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Z-1727-2025Open, ClassifiedMedical Depot Inc.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Z-0795-2025Open, ClassifiedJIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Oxygen concentrator may melt or catch on fire during use.
Showing the 5 most recently initiated of 44. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for CAW?
MAUDE holds 1,407 adverse-event reports naming product code CAW, 423 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in CAW unusual?
One month sits above CAW's own expected range: 1 March 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 10 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 71 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 58 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 58 | Insufficient history | No expected range — too little history | |
| 33 | 3–66 | Within expected (3–66) | |
| 24 | 9–50 | Within expected (9–50) | |
| 66 | 9–54 | Above expected (9–54) | |
| 34 | 12–74 | Within expected (12–74) | |
| 39 | 9–66 | Within expected (9–66) | |
| 52 | 10–69 | Within expected (10–69) | |
| 48 | 21–115 | Within expected (21–115) | |
| 67 | 12–81 | Within expected (12–81) | |
| 64 | 17–94 | Within expected (17–94) | |
| 54 | 22–93 | Within expected (22–93) | |
| 59 | 22–80 | Within expected (22–80) | |
| 58 | 30–90 | Within expected (30–90) | |
| 41 | 33–102 | Within expected (33–102) | |
| 33 | 20–81 | Within expected (20–81) | |
| 64 | 18–83 | Within expected (18–83) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in CAW.
Who has entered CAW in the last year?
7 companies filed in CAW for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Honsun (Nantong) Co., Ltd. | K252399 | |
| Oxytek Medical Technology Co., Ltd. | K252965 | |
| Mv Life, LLC | K252407 | |
| Shenzhen Homed Medical Device Co., Ltd. | K252616 | |
| Shenzhen Harveymed Technology Co., Ltd. | K252268 | |
| Foshan Kycare Medical Equipment Co., Ltd. | K251607 | |
| Nanjing Yinuoji Medical Technology Co., Ltd. | K250625 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in CAW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in CAW?
Across the 287 most recent decisions, these applicants filed most often in CAW.
| Applicant | Recent clearances |
|---|---|
| Invacare Corp. | 15 |
| Mountain Medical Equipment, Inc. | 12 |
| The John Bunn Co. | 8 |
| Airsep Corp. | 7 |
| Nidek Medical Products, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in CAW file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Invacare Corporation | 20 | 2 |
| Airsep Corporation | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch CAW
Get an email the morning anything changes in CAW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.