FDA product code OXQ: Dressing Change Tray

OXQ is the FDA product code for dressing change tray. It is a Class I device, regulated under 21 CFR 880.5075 and reviewed by the General and Plastic Surgery panel. Devices under OXQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 69 recalls for OXQ devices, 39 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 OXQ devices

69 product recalls in 34 recall events; 39 initiated in the last five years and 34 still open. Most recent: 2026-04-27.

Frequently asked questions

What is FDA product code OXQ?

OXQ is the FDA product code for dressing change tray. It is a Class I device, regulated under 21 CFR 880.5075 and reviewed by the General and Plastic Surgery panel.

What device class is OXQ?

Class I, regulation 21 CFR 880.5075. Typical premarket route: 510(k) exempt.

Have OXQ devices been recalled?

Yes: 69 product recalls across 34 recall events; the most recent began 2026-04-27.

Next steps

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