FDA product code DSM: Alarm, Leakage Current, Portable

DSM is the FDA product code for alarm, leakage current, portable. It is a Class I device, regulated under 21 CFR 870.2640 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under DSM. The average 510(k) review took 52 days (median 52).

Classification

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

Top DSM applicants

Most recent DSM clearances

Recalls for DSM devices

openFDA lists no recalls for product code DSM.

Frequently asked questions

What is FDA product code DSM?

DSM is the FDA product code for alarm, leakage current, portable. It is a Class I device, regulated under 21 CFR 870.2640 and reviewed by the Cardiovascular panel.

What device class is DSM?

Class I, regulation 21 CFR 870.2640. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 52 days from receipt to decision (median 52).

Which companies have the most DSM clearances?

Cardio-Dynamics Laboratories, Inc. (1).

Next steps

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