Cleared Traditional

PARAMED PARAFFIN WARMER (K991427) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991427 · Divi Intl. Co. · Physical Medicine device
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Aug 1999
Decision
112d
Days
Class 2
Risk

K991427 is an FDA 510(k) clearance for the PARAMED PARAFFIN WARMER. Classified as Bath, Paraffin (product code IMC), Class II - Special Controls.

Submitted by Divi Intl. Co. (Miami, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5110 - 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 Divi Intl. Co. devices

Submission Details

510(k) Number K991427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date August 13, 1999
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMC Bath, Paraffin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5110
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.