- Applies to
- Medical devices, mostly Class II
- Pathway
- 510(k) premarket notification
- Test
- Substantial equivalence to a predicate
- Typical review
- About 90 days
How clearance works
Most moderate-risk (Class II) devices reach the market through a premarket notification, better known as a 510(k). The maker compares its device with a 'predicate,' a legally marketed device with the same intended use. To be cleared, the new device needs the same technology as the predicate, or different technology that doesn't raise new questions about safety or effectiveness, backed by data.
When the FDA agrees, it issues an order that 'clears' the device for sale. The review is usually completed within about 90 days, much faster than a new drug approval.
Cleared versus approved
The FDA uses three main risk classes for devices, and the pathway depends on the class:
- Class I (low risk), such as exam gloves: general controls only, and most are exempt from a 510(k).
- Class II (moderate risk), such as many catheters and some glucose monitors: usually 'cleared' through a 510(k), or authorized through the De Novo pathway when there's no good predicate.
- Class III (high risk), such as mechanical heart valves: must be 'approved' through premarket approval (PMA), the FDA's most demanding device review, which requires valid scientific evidence of safety and effectiveness.
Why the wording matters
Clearance is a real regulatory step, but it's a comparison, not a fresh demonstration that a device improves health. A cleared device is as safe and effective as its predicate for the same intended use. When a company says its product is 'FDA-approved' but it's actually a cleared device, that's an overstatement.
Clearance also covers a specific intended use. A device cleared for one purpose isn't automatically validated for another.
Where you might see it
Many wellness and testing devices, including some continuous glucose monitors and at-home sample collection devices, are cleared or authorized rather than approved. Laboratory tests can follow other routes too: some are FDA-cleared kits, while many are lab-developed tests run under federal lab certification rules instead. When you see a claim about a device, it's reasonable to ask which pathway it went through and for what use.
A practical tip: the FDA's databases list each cleared device with its intended use. If a product's marketing promises far more than the use it was cleared for, such as diagnosing a disease when it was cleared only to measure a value, treat the extra claims with caution and ask your clinician how to interpret the readings.
FDA-cleared: common questions
Is a cleared device less safe than an approved one?
Not necessarily. Clearance is used for moderate-risk devices, and the review is designed for that level of risk. Approval through PMA is reserved for the highest-risk devices.
Can a drug be FDA-cleared?
No. Drugs are approved, not cleared. Clearance is a device term.
What is a predicate device?
It's the legally marketed device a new device is compared to in a 510(k). The new device doesn't have to be identical, but it must have the same intended use.
What's the De Novo pathway?
It's a route for new low- to moderate-risk devices that have no suitable predicate. Devices authorized this way can later serve as predicates for others.
How do I check whether a device is cleared?
The FDA publishes searchable 510(k), De Novo and PMA databases where you can look up a device by name or maker.
Does 'FDA-registered' mean the same as cleared?
No. Registration means a company told the FDA it exists and what it makes. It doesn't mean any product was reviewed.
Sources
We cite government agencies, professional societies and peer-reviewed research. See our editorial policy.
- Premarket Notification 510(k)U.S. Food and Drug Administration
- Premarket Approval (PMA)U.S. Food and Drug Administration
- Is It Really 'FDA Approved'?U.S. Food and Drug Administration