Cleared Traditional

K832382 - CAREFREE * PANTY SHIELDS-REG/DEOR (FDA 510(k) Clearance)

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

K832382 · Johnson & Johnson Professionals, Inc. · Obstetrics & Gynecology device
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Aug 1983
Decision
24d
Days
Class 2
Risk

K832382 is an FDA 510(k) clearance for the CAREFREE * PANTY SHIELDS-REG/DEOR. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 24 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K832382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date August 12, 1983
Days to Decision 24 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
136d faster than avg
Panel avg: 160d · This submission: 24d
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.