FDA product code OFF: Central Venous Catheter Tray

OFF is the FDA product code for central venous catheter tray. It is a Class II device, regulated under 21 CFR 870.1140 and reviewed by the Cardiovascular panel. Devices under OFF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 50 recalls for OFF devices, 43 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 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 OFF devices

50 product recalls in 45 recall events; 43 initiated in the last five years and 40 still open. Most recent: 2026-08-11.

Frequently asked questions

What is FDA product code OFF?

OFF is the FDA product code for central venous catheter tray. It is a Class II device, regulated under 21 CFR 870.1140 and reviewed by the Cardiovascular panel.

What device class is OFF?

Class II, regulation 21 CFR 870.1140. Typical premarket route: 510(k) exempt.

Have OFF devices been recalled?

Yes: 50 product recalls across 45 recall events; the most recent began 2026-08-11.

Next steps

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