Cleared Traditional

K922575 - ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS

K922575 is an FDA 510(k) clearance for ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS, manufactured by Procter & Gamble Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K922575 · Procter & Gamble Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
246d
Days
Class 1
Risk

K922575 is an FDA 510(k) clearance for the ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS. 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 February 2, 1993 after a review of 246 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.

View all Procter & Gamble Co. devices

FDA 510(k) Submission Details - K922575

510(k) Number K922575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date February 02, 1993
Days to Decision 246 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 160d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

HHD Device Classification - Class 1, General Controls

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.

Regulatory Peers - HHD Pad, Menstrual, Unscented

All 62
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K922575.
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · Procter & Gamble Co. · Jan 2000
GLADRAGS COTTON MENSTRUAL PAD
K980395 · Keepers!, Inc. · Apr 1998
KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
K925250 · Kimberly-Clark Corp. · Mar 1993
NEW FREEDOM ULTRA THIN PADS
K920830 · Kimberly-Clark Corp. · Sep 1992
STAYFREE(TM) MAXI-PAD
K913747 · Personal Products Co. · Nov 1991
O. B. PACK III
K902273 · Customed, Inc. · Aug 1990