Cleared Traditional

SCENTED MENSTRUAL PAD (K832215) - FDA 510(k) Clearance

K832215 · Personal Products Co. · Obstetrics & Gynecology device
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Jul 1983
Decision
47d
Days
-
Risk

K832215 is an FDA 510(k) clearance for the SCENTED MENSTRUAL PAD.

Submitted by Personal Products Co. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Personal Products Co. devices

Submission Details

510(k) Number K832215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1983
Decision Date July 12, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 160d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -