FDA product code KDM: Sigmoidoscope, Rigid, Non-Electrical

KDM is the FDA product code for sigmoidoscope, rigid, non-electrical. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under KDM. The average 510(k) review took 95 days (median 95). FDA has posted 1 recall for KDM devices.

Classification

Compare with all 510(k) review times · Search every KDM clearance

Top KDM applicants

Most recent KDM clearances

Recalls for KDM devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-23.

Frequently asked questions

What is FDA product code KDM?

KDM is the FDA product code for sigmoidoscope, rigid, non-electrical. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is KDM?

Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).

How long does a 510(k) take for product code KDM?

Across 1 cleared submissions the average was 95 days from receipt to decision (median 95).

Which companies have the most KDM clearances?

Sapimed S.P.A. (1).

Have KDM devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2021-04-23.

Next steps

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