FDA product code OFR: Tracheobronchial Suction Catheter Kit

OFR is the FDA product code for tracheobronchial suction catheter kit. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel. Devices under OFR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for OFR devices, 7 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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 OFR devices

7 product recalls in 7 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-07-10.

Frequently asked questions

What is FDA product code OFR?

OFR is the FDA product code for tracheobronchial suction catheter kit. It is a Class I device, regulated under 21 CFR 868.6810 and reviewed by the Anesthesiology panel.

What device class is OFR?

Class I, regulation 21 CFR 868.6810. Typical premarket route: 510(k) exempt.

Have OFR devices been recalled?

Yes: 7 product recalls across 7 recall events; the most recent began 2026-07-10.

Next steps

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