FDA cleared vs approved: what each term means for a medical device

The four terms side by side

FDA sorts devices into three classes by risk. Class I devices such as elastic bandages and exam gloves are mostly exempt from premarket notification. Class II devices generally need a 510(k). The highest-risk Class III devices, such as mechanical heart valves, generally need a PMA. Those examples come from FDA's consumer guide, Is It Really 'FDA Approved'?

What "FDA cleared" means: the 510(k)

A 510(k) is a premarket submission showing that a device is "as safe and effective, that is, substantially equivalent, to a legally marketed device". That existing device is called the predicate. According to FDA's 510(k) page, a device is substantially equivalent when it has the same intended use as the predicate and either the same technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. The submitter must also show it is as safe and effective as the predicate.

When FDA agrees, it sends an order letter, and that order "clears" the device for commercial distribution. FDA says the decision is usually made within 90 days, and it does not typically inspect the manufacturer before clearance. The supporting data can include bench testing, electromagnetic compatibility, software validation, biocompatibility and clinical data.

Predicates form chains you can follow. Garmin's ECG App (K221774, cleared Jan 12, 2023) names Apple's ECG app, De Novo DEN180044, as its predicate in its 510(k) summary. The WHOOP ECG Feature (K243236) names Apple's ECG App 2.0, K201525, which was itself cleared against DEN180044. In our database 5 records list DEN180044 among their predicates (parsed from FDA summaries), including ECG apps from Garmin, Apple, Fitbit, Samsung, AliveCor.

If FDA finds a device not substantially equivalent, the company can resubmit with new data, request De Novo classification, petition for reclassification, or file a PMA.

What "FDA approved" means: the PMA

Premarket approval is FDA's scientific and regulatory review of Class III devices: those that support or sustain human life, are of substantial importance in preventing impairment of health, or present a potential, unreasonable risk of illness or injury. FDA calls it "the most stringent type of device marketing application". Approval rests on FDA's finding that the application contains sufficient valid scientific evidence that the device is safe and effective for its intended use.

For wearables and PPG devices, approval is rare. Our FDA database holds 443 510(k) clearances and 16 De Novo grants. openFDA's PMA records contain none under the product codes it covers: pulse oximeters, photoplethysmograph and ECG software, blood pressure monitors, sleep apnea devices and patient monitors. A smartwatch feature described as "FDA approved" has, in every case in our data, been cleared or granted instead.

What a De Novo grant means

The De Novo pathway classifies novel devices with no legally marketed predicate, when general controls, or general and special controls, give reasonable assurance of safety and effectiveness. A company can request it after FDA finds its 510(k) not substantially equivalent, or go straight to De Novo when it concludes no predicate exists.

When FDA grants the request:

• the device can be marketed;
• FDA creates a classification regulation for the new device type, with special controls for Class II;
• the device can serve as the predicate for later 510(k)s of the same type;
• FDA posts the granting order and publishes a decision summary.

De Novo numbers start with DEN followed by six digits. The first two digits give the calendar year FDA received the request. FDA's MDUFA goal is a decision within 150 review days.

Wearable examples: Apple's ECG app (DEN180044) and Irregular Rhythm Notification Feature (DEN180042) were both granted on Sep 11, 2018. Samsung's Sleep Apnea Feature (DEN230041) was granted on Feb 6, 2024, and Apple's Sleep Apnea Notification Feature (K240929) was later cleared through a 510(k) that names DEN230041 as its predicate.

"FDA registered" and "FDA listed"

Establishments involved in producing and distributing devices for the US must register with FDA every year and generally list the devices they make. Registration tells FDA where devices are made, and FDA is explicit that it implies nothing about approval:

"Mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device, or other drugs or devices of the establishment, nor does it mean that a product may be legally marketed."

Many Class I and some Class II devices are exempt from 510(k). Such a device can be legally sold with no clearance number at all, so a missing number does not by itself mean a product is illegal, and a registration number does not mean it was reviewed.

What one clearance covers

A clearance applies to the device and indications described in that submission. FDA requires a new 510(k) when a change could significantly affect safety or effectiveness, or when the device will be marketed for a new or different intended use. That is why one product can carry several numbers. Apple's records in our database, oldest first:

Each row is a separate feature. A clearance for the ECG app says nothing about the watch's other measurements. When a feature has no FDA record, our database simply has no row for it; whether it needed one is a regulatory question this page does not answer.

Which word to use

How to check a claim yourself

1. Find the FDA number. It starts with K for a 510(k), DEN for a De Novo request and P for a PMA.
2. Look it up in FDA's 510(k), De Novo or PMA database, or search our FDA database by number, company or product code.
3. Read the product code and the indications for use in the FDA summary. They tell you exactly what was cleared and for whom.
4. Check whether the feature you care about is the one named in the record.

Our 510(k) database lookup guide walks through each search field and what the record page shows.