FDA product code PKD: Laceration Tray

PKD is the FDA product code for laceration tray. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel. Devices under PKD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 11 recalls for PKD devices, 11 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 PKD devices

11 product recalls in 11 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2026-03-19.

Frequently asked questions

What is FDA product code PKD?

PKD is the FDA product code for laceration tray. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel.

What device class is PKD?

Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k) exempt.

Have PKD devices been recalled?

Yes: 11 product recalls across 11 recall events; the most recent began 2026-03-19.

Next steps

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