Class II Medical Device: FDA Rules and Examples

This page describes products and general use; it is not medical advice.

Short answer: a Class II medical device is one the US FDA places in the middle of its three risk-based classes. General controls and special controls apply, and unless the device type is exempt, it needs FDA clearance through a 510(k) before it can be marketed in the US. Who uses it: clinic and procurement staff, buyers, quality and regulatory teams, and students checking which FDA class a product sits in.

What does it mean when a medical device is classified as Class II (Class 2)?

FDA has established classifications for approximately 1,700 generic types of device, grouped into 16 medical specialty panels. Each type is assigned to one of three regulatory classes “based on the level of control necessary to assure the safety and effectiveness of the device”. Class II means general controls and special controls, with or without exemptions.

General controls are the baseline requirements of the Federal Food, Drug, and Cosmetic Act that apply to every device in Class I, II and III.
Special controls are added for Class II. FDA states that Class II devices are those for which special controls, combined with general controls, are necessary to provide reasonable assurance of safety and effectiveness.

For a device type covered by a special controls document, FDA says a manufacturer must conform to the general controls, address the specific risks identified (by meeting the guidance recommendations or by other means giving equivalent assurance), and, if the device is not exempt from premarket notification, obtain a substantial equivalence determination before marketing it. FDA’s list of these documents includes a 1990 guidance on 510(k) submissions for implanted infusion ports.

How a device ends up in Class II

The class belongs to a generic device type. Each classified type has a classification regulation in 21 CFR Parts 862 to 892. 21 CFR 880.2920, Clinical Mercury Thermometer, is Class II, with product code FLK.
Intended use and indications matter. FDA’s example is a scalpel, whose intended use is to cut tissue, with a narrower indication added by labeling such as incisions in the cornea. Classification is risk based: Class I is the lowest risk and Class III the greatest.
If a device is not substantially equivalent. Where FDA finds a device not substantially equivalent to a legally marketed predicate, the applicant can resubmit, file a reclassification petition, submit a premarket approval application, or request a Class I or II designation through FDA De Novo classification.
Older devices. A device legally marketed before May 28, 1976, the effective date of the Medical Device Amendments of 1976, can serve as a predicate.

What are Class I, II and III medical devices?

Class I devices carry the lowest risk and Class III the greatest. The class decides the premarket submission FDA expects.

Class	Controls	Premarket route	Records in FDA classification data
Class I	General controls	510(k) unless exempt. FDA states about 572, or 74%, of Class I devices are exempt from premarket notification.	2,403
Class II	General controls and special controls	510(k) unless exempt	3,646
Class III	General controls and premarket approval (PMA)	PMA, except a preamendments device for which PMAs have not been called for, which uses a 510(k)	528

The last column counts records in the openFDA device classification dataset (updated 2026-10-26): 7,097 records, each with a product code, and 520 others carrying different class values. They are product-code records, not devices on the market, but they show Class II is the largest group at 3,646 of 7,097.

What is the difference between Class I and Class II?

Class I devices are subject to general controls only; Class II adds special controls. In FDA’s data, a polymer patient examination glove (21 CFR 880.6250) is Class I and a powered wheelchair (21 CFR 890.3860) is Class II. Both classes use a 510(k) unless exempt.

What does Class III medical device mean?

Class III is the highest-risk class: general controls plus premarket approval, which FDA describes as the required process of scientific review to ensure the safety and effectiveness of Class III devices. In FDA’s data, an implantable pacemaker pulse-generator (21 CFR 870.3610) and a replacement heart valve (21 CFR 870.3925) are Class III.

What are Class 2 medical devices? Examples from FDA records

One classification regulation can cover several product codes: 21 CFR 880.5570 appears on records for a sharps container, an interosseous needle and a thoracentesis tray.

Device type (FDA record)	Classification regulation	Product code	Class
Thermometer, Clinical Mercury	21 CFR 880.2920	FLK	II
Wheelchair, Powered	21 CFR 890.3860	ITI	II
Pump, Infusion, Insulin	21 CFR 880.5725	LZG	II
Drape, Surgical, ENT	21 CFR 878.4370	ERY	II
Container, Sharps	21 CFR 880.5570	MMK	II
Polymer Patient Examination Glove (contrast)	21 CFR 880.6250	LZA	I
Implantable Pacemaker Pulse-Generator (contrast)	21 CFR 870.3610	DXY	III

Class II is not limited to simple accessories: of the 3,646 Class II records, 406 carry the database’s implant flag and 150 its life-sustain/support flag. For product-level readings of a class, see the epidural kit guide and types of medical equipment.

What are Class IIa medical devices?

Class IIa is a European Union class, not an FDA class. Regulation (EU) 2017/745 (the Medical Device Regulation) divides devices into classes I, IIa, IIb and III, taking into account intended purpose and inherent risks, and classifies them under Annex VIII (Article 51). The FDA and EU systems are separate, so a class stated under one does not replace a class assigned under the other.

Conformity assessment differs by class (Article 52). Manufacturers of class IIa devices, other than custom-made or investigational devices, follow Annex IX Chapters I and III, including assessment of the technical documentation of at least one representative device for each category of devices. For class I devices, the manufacturer issues an EU declaration of conformity after drawing up technical documentation; devices placed on the market sterile, with a measuring function, or as reusable surgical instruments follow additional procedures.

How to check if a device is FDA cleared

FDA’s order finding a device substantially equivalent “clears” it for commercial distribution. FDA publishes searchable databases for checking this:

Find the class and product code in the Product Classification database, which lists a three-letter product code and device class for each device name.
Search the 510(k) database by 510(k) number, applicant, device name or product code. Devices@FDA catalogs cleared and approved device information from the 510(k) and PMA databases, with links to the summary, manufacturer, approval date and user instructions.
Class III devices go through premarket approval, so look in the PMA database. De Novo classification orders are in the De Novo database.
Check the listing. The Registration and Listing database holds establishments and device listings; an owner whose device needs a premarket submission should also give its 510(k), De Novo, PMA, PDP or HDE number.
Match the use. Classification depends on intended use and indications for use, so compare the cleared indications with the product you hold. The 510(k) summary guide explains how to read the record, and the Special, Abbreviated and Traditional 510(k) comparison explains the submission types.

Where to find adverse event and recall records

FDA’s MAUDE database holds adverse event reports about devices, and its recalls database lists medical device recalls classified since November 1, 2002.

Common mistakes

Calling a Class II device “FDA approved”. FDA’s 510(k) order clears a device; premarket approval is the review required for Class III.
Assuming every Class II device needs a 510(k). FDA lists Class II both with and without exemptions.
Reading a US class as an EU class. The EU uses I, IIa, IIb and III under its own regulation.