Cleared Traditional

K252396 - Cryo Sport 2.0 (AVA 501)

K252396 is an FDA 510(k) clearance for Cryo Sport 2.0 (AVA 501), manufactured by Avanutri Equipamentos DE Saúde. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K252396 · Avanutri Equipamentos DE Saúde · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
302d
Days
Class 2
Risk

K252396 is an FDA 510(k) clearance for the Cryo Sport 2.0 (AVA 501). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Avanutri Equipamentos DE Saúde (Tres Rios, BR). The FDA issued a Cleared decision on May 29, 2026 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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. Elevated predicate reliance profile. 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 Avanutri Equipamentos DE Saúde devices

FDA 510(k) Submission Details - K252396

510(k) Number K252396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2025
Decision Date May 29, 2026
Days to Decision 302 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
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Consultant

Bhp Consulting, LLC
Bruno Milhoci

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 130
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K252396.
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