FDA product code PUI: Drape, Surgical, Exempt

PUI is the FDA product code for drape, surgical, exempt. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. Devices under PUI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 41 recalls for PUI devices, 25 initiated in the last five years.

Definition

This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Classification

Recalls for PUI devices

41 product recalls in 13 recall events; 25 initiated in the last five years and 24 still open. Most recent: 2026-01-28.

Frequently asked questions

What is FDA product code PUI?

PUI is the FDA product code for drape, surgical, exempt. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.

What device class is PUI?

Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.

Have PUI devices been recalled?

Yes: 41 product recalls across 13 recall events; the most recent began 2026-01-28.

Next steps

• Run an FDA pathway report with predicate devices for product code PUI
• Run a recall and safety report across every PUI manufacturer
• Watch product code PUI for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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