What is the USFDA Classification of an Oxygen Mask?

USFDA classification of an oxygen mask places it under class I medical devices, meaning it has a low risk to users and is regulated with general controls. These devices are used externally to deliver oxygen from the source to the patient and are considered simple in design and function. As a result, oxygen masks usually do not require premarket approval. The USFDA tracks them using the product code BYG and the regulation number 21 CFR 868.5580, ensuring that they are manufactured, labeled, and marketed safely.

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What Device Class Does the USFDA Assign to An Oxygen Mask?

The USFDA classifies an oxygen mask as a Class I medical device. This means it has a low risk to users and is subject to general controls, but does not usually require premarket approval. Oxygen masks fall under the product code BYG and are regulated under 21 CFR 868.5580. Since they are simple, low-risk devices used to deliver oxygen, the USFDA does not require them to go through complex approval processes.

The USFDA classification of an oxygen mask is class I
Most Class I devices are exempt from the 510 premarket notification
Oxygen masks are used to provide oxygen from a gas supply to the patients
Product Code: BYG | Regulation Number: 21 CFR 868.5580
They are considered safe with proper labeling, manufacturing, and usage

What is the USFDA Product Code And Regulation Number for an Oxygen Mask?

The USFDA product code for an oxygen mask is BYG, and it falls under the regulation number 21 CFR 868.5580.

USFDA product Code: BYG
USFDA Regulation Number: 21 CFR 868.5580
Device Name: Oxygen Mask
USFDA Classification: Class I (General Controls, Low Risk)
Use: Supplies Oxygen from a source patient safely

Why is the USFDA Classification of An Oxygen Mask Class I?

The USFDA classification of an oxygen mask as class I is because it is a low-risk medical device that performs a basic but important function, delivering oxygen from a supply source to the patient. Since it does not involve complex technology or pose a high health risk when used correctly, the USFDA places it under Class I, which requires general controls but no premarket approval.

Low Risk – It does not go inside the body or interact with blood or tissues
Simple Use – It is used externally on the face and does not involve complex machinery
No Life Sustaining Role – It supports breathing but is not used in life critical systems.
Easily Controlled – Its safety can be ensured safely through basic manufacturing and labeling rules.
Minimal Regulatory Burden – Class I devices are usually exempt from premarket notification (510(k)).

Is Premarket Notification Required for USFDA Classification of An Oxygen Mask?

No, premarket notification (510(k)) is not required for the USFDA classification of an oxygen mask. The USFDA classification of an oxygen mask falls under class I medical devices, which are considered low-risk. Most class I devices, including oxygen masks, are exempt from 510 (k) pre-market notification, meaning manufacturers do not need to submit a 510(k) application before marketing them in the US.

Low-risk device
Well-known design and usage
Does not support or sustain life
Meets general controls under USFDA regulations

What USFDA General Controls Apply to a Class I Oxygen Mask?

The USFDA classification of an oxygen mask as a class I medical device generally means it is regulated under general controls to ensure safety and effectiveness.

Establishment Registration
Medical Device Listing
Labeling Requirements
Good Manufacturing Practices
Prohibition of Misbranding
Prohibition of Adulteration

Are There USFDA-Recognised Standards for Oxygen Mask Classification?

Yes, there are you can check out the USFDA recognised standards for oxygen mask classification here:

ISO 10993 series – For biocompatibility testing (to ensure the mask materials are safe when in contact with the skin or respiratory tract.
ISO 13485 – For quality management systems in medical device manufacturing.
ISO 15001/ISO 18562 series – Related to breathing system gas pathways for biocompatibility and cleanliness.
ASTM F2100 – Standard for materials used in medical face masks.

Do Oxygen Mask Manufacturers Need to Register Establishments with USFDA?

Yes, oxygen mask manufacturers should register their establishment with the USFDA. This is a mandatory requirement for all companies involved in the production distribution of Class I medical devices like oxygen masks.

What are Post Market Requirements Under USFDA Classification for Oxygen Masks?

Here check out this table to understand the post-market requirements under USFDA classification for oxygen masks:

S.No.	Requirements	What it Means
1.	Establishment Registration	Manufacturing should register with the USFDA and renew it every year.
2.	Device Listing	Oxygen masks should be listed with the USFDA under the correct product code
3.	Labeling Compliance	Labels should include the proper product name, manufacturer info, and usage instructions
4.	Good Manufacturing Practices (GMP)	Follow basic quality controls under the USFDA’s Quality System Regulation (QSR)
5.	Compliant Handling	Maintain records of customer complaints and take action it needed
6.	Medical Device Reporting (MDR)	Report serious issues or injuries caused by the oxygen masks to the USFDA
7.	Corrections and Recalls	If a problem is found, the manufacturer should fix it or recall the product if needed.
8.	Inspection by the USFDA	Be ready for USFDA inspection to ensure ongoing compliance

How Does the USFDA Classification of an Oxygen Mask Affect Import and Distribution?

The USFDA classification of an oxygen mask directly affects how it can be imported and distributed. Since most oxygen is a class I medical device, it follows general controls but still should meet important USFDA rules.

Registration and Listing Required
No Premarket Approval Needed
Labeling Should Meet USFDA Rules
Good Manufacturing Practices
Customs Clearance Depends on Compliance

What Happens if an Oxygen Mask is Wrongly Classified By USFDA?

If the USFDA Classification of an oxygen mask is wrong, it can lead to serious problems for the manufacturer, importer, and even the users.