Anesthesia Conduction Kit

What Is It?

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.

What Is FDA Product Code CAZ?

Anesthesia Conduction Kit is FDA product code CAZ, Class 2, 21 CFR 868.5140.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 267 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 220 recalls under this product code since 2001. None was by a company in China. 11 are Class I, the most serious grade.

The root causes the FDA records most often are Packaging process control (30), Incorrect or no expiration date (13) and Nonconforming Material/Component (12). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.