FDA product code QTN: Orally Ingested Transient Device For Constipation

QTN is the FDA product code for orally ingested transient device for constipation. It is a Class II device, regulated under 21 CFR 876.5940 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under QTN, 2 in the last five years. The average 510(k) review took 96 days (median 96). 1 De Novo request was granted under it.

Definition

An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.

Classification

510(k) clearances per year for QTN

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

Top QTN applicants

Most recent QTN clearances

Recalls for QTN devices

openFDA lists no recalls for product code QTN.

Frequently asked questions

What is FDA product code QTN?

QTN is the FDA product code for orally ingested transient device for constipation. It is a Class II device, regulated under 21 CFR 876.5940 and reviewed by the Gastroenterology and Urology panel.

What device class is QTN?

Class II, regulation 21 CFR 876.5940. Typical premarket route: 510(k).

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

Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).

Which companies have the most QTN clearances?

Vibrant, Ltd. (2).

Next steps

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