FDA product code PWY: Lumbar Puncture Tray (Adult & Pediatric)

PWY is the FDA product code for lumbar puncture tray (adult & pediatric). It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. Devices under PWY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 21 recalls for PWY devices, 14 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 PWY devices

21 product recalls in 5 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2026-05-21.

Frequently asked questions

What is FDA product code PWY?

PWY is the FDA product code for lumbar puncture tray (adult & pediatric). It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.

What device class is PWY?

Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k) exempt.

Have PWY devices been recalled?

Yes: 21 product recalls across 5 recall events; the most recent began 2026-05-21.

Next steps

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