FDA product code PSP: Intracranial Pressure & Temperature Monitoring Kit

PSP is the FDA product code for intracranial pressure & temperature monitoring kit. It is a Class II device, regulated under 21 CFR 882.1620 and reviewed by the Neurology panel. Devices under PSP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PSP devices, 1 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 PSP devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-18.

Frequently asked questions

What is FDA product code PSP?

PSP is the FDA product code for intracranial pressure & temperature monitoring kit. It is a Class II device, regulated under 21 CFR 882.1620 and reviewed by the Neurology panel.

What device class is PSP?

Class II, regulation 21 CFR 882.1620. Typical premarket route: 510(k) exempt.

Have PSP devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-18.

Next steps

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