FDA product code PQE: Ostomy Care Kit

PQE is the FDA product code for ostomy care kit. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. Devices under PQE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PQE devices.

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 PQE devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-10-26.

Frequently asked questions

What is FDA product code PQE?

PQE is the FDA product code for ostomy care kit. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.

What device class is PQE?

Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.

Have PQE devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2017-10-26.

Next steps

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