Cleared Special

K260453 - Remote Wave Electrode (AE03-50) (FDA 510(k) Clearance)

Also includes:
Remote Wave Electrode (AE03-60)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260453 · Bionit Labs Srl · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
29d
Days
Class 2
Risk

K260453 is an FDA 510(k) clearance for the Remote Wave Electrode (AE03-50). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bionit Labs Srl (Soleto, IT). The FDA issued a Cleared decision on March 12, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.1320 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bionit Labs Srl devices

Submission Details

510(k) Number K260453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2026
Decision Date March 12, 2026
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 433
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K260453.
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