FDA product code PTW: System, Peritoneal, Automatic Delivery, Exempt

PTW is the FDA product code for system, peritoneal, automatic delivery, exempt. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. Devices under PTW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

This product code is the class II exempt counterpart of FKX, 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 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Classification

Recalls for PTW devices

openFDA lists no recalls for product code PTW.

Frequently asked questions

What is FDA product code PTW?

PTW is the FDA product code for system, peritoneal, automatic delivery, exempt. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.

What device class is PTW?

Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k) exempt.

Next steps

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