Cleared Traditional

K014208 - SSIR SYSTEM

K014208 is an FDA 510(k) clearance for SSIR SYSTEM, manufactured by Russian-American Technology Associates, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K014208 · Russian-American Technology Associates, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
193d
Days
Class 2
Risk

K014208 is an FDA 510(k) clearance for the SSIR SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Russian-American Technology Associates, Inc. (Houston, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 193 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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.

FDA 510(k) Submission Details - K014208

510(k) Number K014208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date July 02, 2002
Days to Decision 193 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
77d slower than avg
Panel avg: 116d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 228
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K014208.
WS-501 HEAT LAMP
K013197 · Lhasa Medical, Inc. · Aug 2002
MHS MED LIGHT 1000
K021956 · Micro Health Systems, Inc. · Aug 2002
MEDX 1000 SERIES
K020017 · Medx Electronics, Inc. · Jul 2002
BIOLIGHT PCD
K011355 · Biolight International AB · Jan 2002
MU PHOTONICS PAIN THERAPIST
K012508 · Nu Photonics, Inc. · Oct 2001
TDP CQ-27 HEAT LAMP
K003538 · Lhasa Medical, Inc. · Jun 2001
K014208 · SSIR SYSTEM
Download PDF FDA Summary Russian-American Tech…