Cleared Traditional

K854151 - HOMECARE CLINICS INFRAHEAT #230

K854151 is the FDA 510(k) clearance for HOMECARE CLINICS INFRAHEAT #230 by Nelkin/Piper Intl.. It is a Class 2 Physical Medicine device (product code ILY) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K854151 · Nelkin/Piper Intl. · Physical Medicine device
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Jan 1986
Decision
111d
Days
Class 2
Risk

K854151 is an FDA 510(k) clearance for the HOMECARE CLINICS INFRAHEAT #230. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Nelkin/Piper Intl. (Kansas City, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 111 days - within the typical 510(k) review window.

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.

View all Nelkin/Piper Intl. devices

Submission Details

510(k) Number K854151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1985
Decision Date January 30, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.