FDA product code PPD: Universal Drainage Tray

PPD is the FDA product code for universal drainage tray. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under PPD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for PPD devices, 4 initiated in the last five years.

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Classification

Recalls for PPD devices

4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-12-04.

Frequently asked questions

What is FDA product code PPD?

PPD is the FDA product code for universal drainage tray. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.

What device class is PPD?

Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k) exempt.

Have PPD devices been recalled?

Yes: 4 product recalls across 3 recall events; the most recent began 2025-12-04.

Next steps

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