Cleared Traditional

K890655 - NEW FREEDOM THIN DEODORANT MAXI PADS (FDA 510(k) Clearance)

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

K890655 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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May 1989
Decision
82d
Days
Class 2
Risk

K890655 is an FDA 510(k) clearance for the NEW FREEDOM THIN DEODORANT MAXI PADS. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Washington, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5425 - 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 Kimberly-Clark Corp. devices

Submission Details

510(k) Number K890655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1989
Decision Date May 01, 1989
Days to Decision 82 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
78d faster than avg
Panel avg: 160d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHL Pad, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5425
Definition Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b).
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 Obstetrics & Gynecology devices follow this clearance model.