FDA PRODUCT CODE · CLASS II
CAW — Generator, Oxygen, Portable
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is a candidate for a third party review program
SPEQ READINGAn Accredited Person may conduct the 510(k) review instead of FDA. FDA still makes the clearance decision — third-party review changes who reviews, never who decides.
Other product codes under 21 CFR 868.5440
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 868.5440 — Portable oxygen generator
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
(b) Classification. Class II (performance standards).
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 21, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 868.5440 on eCFR →
Recent clearances
Recent recalls
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
Oxygen concentrator may melt or catch on fire during use.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for m
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →