bite away two— 510(k) K250047

Name: FDA 510(k) clearance K250047
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Substantially Equivalent

mibeTec GmbH

FDA 510(k) clearance K250047 for bite away two, Substantially Equivalent on 2025-09-12. Applicant: mibeTec GmbH. Device class: 2.

Clearance details

Applicant: mibeTec GmbH
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 2025-01-10
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brehna, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRT

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K220514 — bite away neo2022-06-23
K160943 — Bite Away2016-08-26
K142228 — Heated Eye Pad2015-02-09
K133981 — AVACEN 1002014-08-15
K111273 — FIR HEAT THERAPHY SYSYEMS2011-11-08

Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.