FDA product code SDC: Qualitative Cleaning Process Protein Indicator

SDC is the FDA product code for qualitative cleaning process protein indicator. It is a Class II device, regulated under 21 CFR 880.6930 and reviewed by the General Hospital panel. Devices under SDC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 2 recalls for SDC devices, 2 initiated in the last five years.

Definition

A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.

Classification

Recalls for SDC devices

2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-07-29.

Frequently asked questions

What is FDA product code SDC?

SDC is the FDA product code for qualitative cleaning process protein indicator. It is a Class II device, regulated under 21 CFR 880.6930 and reviewed by the General Hospital panel.

What device class is SDC?

Class II, regulation 21 CFR 880.6930. Typical premarket route: 510(k).

Have SDC devices been recalled?

Yes: 2 product recalls across 1 recall events; the most recent began 2026-07-29.

Next steps

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