FDA product code OHR: Catheter Care Tray

OHR is the FDA product code for catheter care tray. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under OHR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 16 recalls for OHR devices, 13 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 OHR devices

16 product recalls in 10 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2026-05-04.

Frequently asked questions

What is FDA product code OHR?

OHR is the FDA product code for catheter care tray. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.

What device class is OHR?

Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k) exempt.

Have OHR devices been recalled?

Yes: 16 product recalls across 10 recall events; the most recent began 2026-05-04.

Next steps

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