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Cleared, approved, De Novo, Breakthrough: how FDA medical device pathways work

By the Future Health Media desk · Sep 29, 2026 · Checked against the primary sources listed below. Not medically reviewed; this is journalism, not medical advice.

What is the difference between FDA-cleared and FDA-approved? "Cleared" usually means a device went through the 510(k) pathway by showing it is substantially equivalent to a device already on the market. "Approved" means it went through premarket approval (PMA), the stricter pathway for the highest-risk Class III devices, which requires valid scientific evidence that the device is safe and effective. A De Novo request is "granted" for novel low-to-moderate-risk devices with no predicate.

The four words you'll see most

510(k) — "cleared"
A premarket submission showing the new device is "as safe and effective, that is, substantially equivalent, to a legally marketed device" (FDA). Most devices reach the market this way.
De Novo — "granted"
A pathway "to classify novel medical devices" where general or special controls give reasonable assurance of safety and effectiveness "but for which there is no legally marketed predicate device" (FDA). Example: Houston's Saranas received De Novo classification for its Early Bird bleed monitor in 2019.
PMA — "approved"
Premarket approval for Class III devices — those that support or sustain life or present potentially unreasonable risk. The applicant must provide "sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)" (FDA).
IDE — investigational
An investigational device exemption "allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data" (FDA). It is not a marketing authorization. Houston's Procyrion is studying its Aortix pump under an IDE in the DRAIN-HF pivotal trial.

Breakthrough designation isn't approval

The Breakthrough Devices Program speeds up development and review for devices that could more effectively treat or diagnose life-threatening or irreversibly debilitating conditions. A designated device still has to earn clearance, a De Novo grant or approval. Austin's Alleviant Medical holds Breakthrough designation for its no-implant interatrial shunt, which is still investigational.

How to read a company's claim

  • "FDA-approved" on a 510(k) device is wrong. The correct word is "cleared."
  • "Breakthrough" describes a review program, not proof the device works.
  • "In a pivotal trial" means the device is still investigational. Houston's EndoQuest Robotics, for example, has started its pivotal study but has not received FDA clearance.

Companies in this story

SaranasHouston · MedTechMakes the Early Bird Bleed Monitoring System, which uses bioimpedance sensors to detect internal bleeding during endovascular procedures.Alleviant MedicalAustin · MedTechDeveloping a no-implant interatrial shunt for heart failure: a single procedure creates a connection between the heart's upper chambers without leaving a permanent implant.ProcyrionHouston · MedTechDeveloping Aortix, a percutaneous mechanical circulatory support device for heart failure patients with cardiorenal syndrome.EndoQuest RoboticsHouston · MedTechDeveloping a flexible robotic Endoluminal Surgical (ELS) System for gastrointestinal procedures performed through the body's natural openings.

Sources

  1. FDA: Premarket Notification 510(k)
  2. FDA: De Novo Classification Request
  3. FDA: Premarket Approval (PMA)
  4. FDA: Investigational Device Exemption (IDE)
  5. FDA: Breakthrough Devices Program

Spotted an error? Request a correction. Disclosure: if a company named here is a client of our publisher, Pantheon Media, the story says so.

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