Cleared Traditional

K894229 - NEW FREEDOM ANYDAY PANTILINERS (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K894229 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Nov 1989
Decision
161d
Days
Class 1
Risk

K894229 is an FDA 510(k) clearance for the NEW FREEDOM ANYDAY PANTILINERS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Washington, US). The FDA issued a Cleared decision on November 27, 1989 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K894229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date November 27, 1989
Days to Decision 161 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
1d slower than avg
Panel avg: 160d · This submission: 161d
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.