Cleared Traditional

K931261 - SPECTROPAD SYSTEM

K931261 is an FDA 510(k) clearance for SPECTROPAD SYSTEM, manufactured by Smi. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K931261 · Smi · Physical Medicine device
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Mar 1994
Decision
384d
Days
Class 2
Risk

K931261 is an FDA 510(k) clearance for the SPECTROPAD SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Smi (Lakewood, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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FDA 510(k) Submission Details - K931261

510(k) Number K931261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1993
Decision Date March 31, 1994
Days to Decision 384 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 115d · This submission: 384d
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 157
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K931261.
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
K954577 · C.A.I. Industries Corp. · May 1997
THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
K963728 · China Chongqing Bashan Instrument Factory · Dec 1996
FIRARD II/ TDP LAMP
K960036 · Helio Medical Supplies, Inc. · Jun 1996
OLYMPIC WARM-LAMP
K932881 · Olympic Medical Corp. · Jan 1994