FDA product code JED: Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

JED is the FDA product code for analyzer, oxyhemoglobin concentration, blood-phase, indwelling. It is a Class III device, regulated under 21 CFR 868.1120 and reviewed by the Anesthesiology panel. Devices under JED reach the market by PMA; FDA lists no cleared 510(k)s for it.

Definition

A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Classification

Recalls for JED devices

openFDA lists no recalls for product code JED.

Frequently asked questions

What is FDA product code JED?

JED is the FDA product code for analyzer, oxyhemoglobin concentration, blood-phase, indwelling. It is a Class III device, regulated under 21 CFR 868.1120 and reviewed by the Anesthesiology panel.

What device class is JED?

Class III, regulation 21 CFR 868.1120. Typical premarket route: PMA.

Next steps

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