Cleared Traditional

K830144 - PANTY-LINERS SCENTED (FDA 510(k) Clearance)

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

K830144 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology device
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Jan 1983
Decision
4d
Days
Class 2
Risk

K830144 is an FDA 510(k) clearance for the PANTY-LINERS SCENTED. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 4 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K830144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1983
Decision Date January 21, 1983
Days to Decision 4 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
156d faster than avg
Panel avg: 160d · This submission: 4d
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.