FDA 510(k) Glossary · regulatory

Device Classification - Class I, II and III

FDA device classification assigns every medical device to one of three risk-based classes. Class I devices are low risk and subject to general controls only. Class II devices require 510(k) premarket notification and special controls. Class III devices are high risk and require Premarket Approval (PMA) with clinical evidence.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
The 510k Database covers Class I and Class II 510(k) submissions. Class II devices represent the large majority of all 166,200 clearance records.

Definition

The FDA's device classification system assigns every medical device to one of three classes based on the level of regulatory control needed to ensure safety and effectiveness. This framework was established by the Medical Device Amendments of 1976 and is codified in Title 21 of the Code of Federal Regulations.

The Three Device Classes

ClassRisk LevelRegulatory PathwayExamples
Class I Low risk General controls only; most are 510(k) exempt Tongue depressors, elastic bandages, manual stethoscopes
Class II Moderate risk 510(k) premarket notification + special controls X-ray systems, infusion pumps, surgical sutures
Class III High risk Premarket Approval (PMA) with clinical evidence Implantable pacemakers, cochlear implants, breast implants

How Classification is Determined

Device class is determined by the applicable product classification regulation in 21 CFR. Each product code is assigned a class. For novel devices without an existing classification, manufacturers may request a Pre-Submission meeting with the FDA or submit a De Novo Classification Request to obtain a new Class I or II designation.

Dataset Context

The 510k Database tracks 166,200 submissions, the majority of which are Class II devices cleared through the 510(k) pathway. Class I devices with a 510(k) requirement are a minority of submissions. Search by device class using the product code filter to identify clearances within specific classifications.

FDA References

Related Terms

510(k) Premarket Notification - De Novo Classification - Product Code - Special Controls - General Controls

Frequently Asked Questions

The FDA classifies medical devices into three classes based on risk: Class I (low risk) - subject to general controls only, most are 510(k) exempt; Class II (moderate risk) - requires 510(k) clearance and compliance with special controls; Class III (high risk) - requires Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The Medical Device Amendments of 1976 established this framework.

The 510(k) premarket notification pathway is used primarily for Class II devices. Some Class I devices that are not exempt may also require a 510(k). Class III devices generally require Premarket Approval (PMA), though some may be eligible for the De Novo pathway if they are of low-to-moderate risk and lack a valid predicate.

Device class is determined by the FDA's product classification system, accessible through accessdata.fda.gov. The class depends on the device's intended use, technological characteristics, and the level of regulation needed to provide reasonable assurance of safety and effectiveness. Manufacturers can request a classification determination if their device does not fit existing categories.

Yes. The FDA can reclassify devices downward (from Class III to Class II or I) through a formal petition process if evidence supports that less stringent controls are sufficient. The De Novo pathway is also a mechanism for classifying novel devices into Class I or II when they would otherwise default to Class III.