FDA product code PAD: Chest Drainage Kit

PAD is the FDA product code for chest drainage kit. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. Devices under PAD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 20 recalls for PAD devices, 6 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 www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Classification

Recalls for PAD devices

20 product recalls in 8 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-04-27.

Frequently asked questions

What is FDA product code PAD?

PAD is the FDA product code for chest drainage kit. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.

What device class is PAD?

Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.

Have PAD devices been recalled?

Yes: 20 product recalls across 8 recall events; the most recent began 2026-04-27.

Next steps

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