Cleared Traditional

K012629 - ALWAYS DUETS (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K012629 · Procter & Gamble Co. · Obstetrics & Gynecology device
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Oct 2001
Decision
53d
Days
Class 1
Risk

K012629 is an FDA 510(k) clearance for the ALWAYS DUETS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on October 5, 2001 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5435 - the FDA obstetrics and gynecology 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: 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 Procter & Gamble Co. devices

Submission Details

510(k) Number K012629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date October 05, 2001
Days to Decision 53 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 160d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HHD Pad, Menstrual, Unscented
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5435
Definition An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.