Cleared Traditional

STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD (K911637) - FDA 510(k) Clearance

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

K911637 · Personal Products Co. · Neurology device
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Aug 1991
Decision
113d
Days
Class 2
Risk

K911637 is an FDA 510(k) clearance for the STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD. Classified as Rongeur, Powered (product code HAD), Class II - Special Controls.

Submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on August 2, 1991 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4845 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K911637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date August 02, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAD Rongeur, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4845
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 Neurology devices follow this clearance model.