FDA product code HFK: Mold, Vaginal

HFK is the FDA product code for mold, vaginal. It is a Class II device, regulated under 21 CFR 884.3900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HFK. The average 510(k) review took 599 days (median 599).

Classification

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

Top HFK applicants

Most recent HFK clearances

Recalls for HFK devices

openFDA lists no recalls for product code HFK.

Frequently asked questions

What is FDA product code HFK?

HFK is the FDA product code for mold, vaginal. It is a Class II device, regulated under 21 CFR 884.3900 and reviewed by the Obstetrics and Gynecology panel.

What device class is HFK?

Class II, regulation 21 CFR 884.3900. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 599 days from receipt to decision (median 599).

Which companies have the most HFK clearances?

Medsurg Industries, Inc. (1).

Next steps

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