FDA product code PWM: Admission Kit (Patient Utensil)

PWM is the FDA product code for admission kit (patient utensil). It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel. Devices under PWM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

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 PWM devices

openFDA lists no recalls for product code PWM.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• G0379 — Direct admission of patient for hospital observation care

Frequently asked questions

What is FDA product code PWM?

PWM is the FDA product code for admission kit (patient utensil). It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel.

What device class is PWM?

Class I, regulation 21 CFR 880.6730. Typical premarket route: 510(k) exempt.

Next steps

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