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The Tracker / December 2025 / K253664

510(k) cleared

SKOUT system

Iterative Health · Dec 22, 2025 · K253664

FDA cleared the SKOUT system from Iterative Health on Dec 22, 2025 under K253664, a special 510(k). The device falls under product code QNP, Gastrointesinal Lesion Software Detection System, regulated at 21 CFR 876.1520 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 20, 2025. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Iterative Health in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253664?

K253664 is the FDA 510(k) for SKOUT system, submitted by Iterative Health. FDA's decision date was Dec 22, 2025, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the SKOUT system?

Iterative Health, based in Cambridge, MA, is the applicant of record for K253664.

How long did the K253664 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Dec 22, 2025, 32 days later.

← All decisions in December 2025