FDA product code OHM: Cesarean Section Tray

OHM is the FDA product code for cesarean section tray. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel. Devices under OHM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 74 recalls for OHM devices, 35 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 OHM devices

74 product recalls in 39 recall events; 35 initiated in the last five years and 33 still open. Most recent: 2026-07-29.

Frequently asked questions

What is FDA product code OHM?

OHM is the FDA product code for cesarean section tray. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel.

What device class is OHM?

Class II, regulation 21 CFR 884.1720. Typical premarket route: 510(k) exempt.

Have OHM devices been recalled?

Yes: 74 product recalls across 39 recall events; the most recent began 2026-07-29.

Next steps

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

All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times