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The Tracker / September 2025 / K250047

510(k) cleared

bite away two

mibeTec GmbH · Sep 12, 2025 · K250047

FDA cleared the bite away two from mibeTec GmbH on Sep 12, 2025 under K250047, a traditional 510(k). The device falls under product code IRT, Pad, Heating, Powered, regulated at 21 CFR 890.5740 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jan 10, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for mibeTec GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250047?

K250047 is the FDA 510(k) for bite away two, submitted by mibeTec GmbH. FDA's decision date was Sep 12, 2025, under product code IRT (Pad, Heating, Powered).

Who makes the bite away two?

mibeTec GmbH, based in Brehna, is the applicant of record for K250047.

How long did the K250047 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Sep 12, 2025, 245 days later.

← All decisions in September 2025