Cleared Traditional

K250047 - bite away two

K250047 is an FDA 510(k) clearance for bite away two, manufactured by mibeTec GmbH. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K250047 · mibeTec GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
245d
Days
Class 2
Risk

K250047 is an FDA 510(k) clearance for the bite away two. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by mibeTec GmbH (Brehna, DE). The FDA issued a Cleared decision on September 12, 2025 after a review of 245 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all mibeTec GmbH devices

FDA 510(k) Submission Details - K250047

510(k) Number K250047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2025
Decision Date September 12, 2025
Days to Decision 245 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IRT Pad, Heating, Powered

All 10
Devices cleared under the same product code (IRT) and FDA review panel - the closest regulatory comparables to K250047.
bite away neo
K220514 · mibeTec GmbH · Jun 2022
FEMININE HEAT WRAP
K924970 · Conair Corp. · Oct 1994
ELASTOPLAST HEAT PLASTER
K925630 · Beiersdorf, Inc. · Feb 1994
ARTHRITIC HEAT WRAP
K925820 · Conair Corp. · Feb 1994
MOIST HEAT PAD
K924799 · Conair Corp. · Oct 1993
MOSIST HEAT PAD WITH AUTOMATIC OFF
K924800 · Conair Corp. · Oct 1993