CATEGORY: CLASSIFICATION

Class II Medical Device

Moderate risk medical devices that typically require a 510(k) clearance in the US. Examples include powered wheelchairs, infusion pumps, and surgical drapes. Most medical devices fall into this category.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

WHEN IT APPLIES

Class II devices present moderate risk and typically need 510(k) in the US (with exemptions). Classification drives testing, clinical expectations, and postmarket burden.

PROCESS / STEPS

Confirm product code and class.
Select pathway (often 510(k)).
Plan performance testing and labeling.
Maintain QMS and postmarket reporting.

EXAMPLES

Many infusion pumps and monitoring accessories are Class II.

RELATED GUIDES & TOOLS

SOURCES

FDA Classify Your Medical Device ↗

Track regulatory signals related to Class II Medical Device across 27 authorities in real time.

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