FDA product code OFM: Phlebotomy Blood Collection Kit

OFM is the FDA product code for phlebotomy blood collection kit. It is a Class II device, regulated under 21 CFR 870.2750 and reviewed by the General Hospital panel. Devices under OFM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for OFM 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 OFM devices

3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-23.

Frequently asked questions

What is FDA product code OFM?

OFM is the FDA product code for phlebotomy blood collection kit. It is a Class II device, regulated under 21 CFR 870.2750 and reviewed by the General Hospital panel.

What device class is OFM?

Class II, regulation 21 CFR 870.2750. Typical premarket route: 510(k) exempt.

Have OFM devices been recalled?

Yes: 3 product recalls across 3 recall events; the most recent began 2026-07-23.

Next steps

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