Cleared Traditional

K241395 - Active System

Also marketed or referenced as:
Avenue8

K241395 is an FDA 510(k) clearance for Active System, manufactured by Caerus Corporation. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K241395 · Caerus Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
216d
Days
Class 2
Risk

K241395 is an FDA 510(k) clearance for the Active System. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Caerus Corporation (Blaine, US). The FDA issued a Cleared decision on December 18, 2024 after a review of 216 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 Caerus Corporation devices

FDA 510(k) Submission Details - K241395

510(k) Number K241395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2024
Decision Date December 18, 2024
Days to Decision 216 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 116d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

All 12
Devices cleared under the same product code (ILX) and FDA review panel - the closest regulatory comparables to K241395.
Pulsed electromagnetic field wrap
K202337 · Hi-Dow International, Inc. · Dec 2020
RecoveryRx
K190251 · Bioelectronics Corporation · Jun 2019
PROVANT THERAPY SYSTEM
K131979 · Regenesis Biomedical, Inc. · Dec 2013
ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
K121702 · Orthocor Medical · May 2013
ZEOBI
K121338 · Ivivi Health Science, LLC · Jul 2012
PROVANT SYSTEM, MODEL 4201
K091791 · Regenesis Biomedical, Inc. · Apr 2010