Cleared Traditional

K850955 - ALWAYS MAXIPADS - UNSCENTED

K850955 is the FDA 510(k) clearance for ALWAYS MAXIPADS - UNSCENTED by Procter & Gamble Mfg. Co.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K850955 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology device
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May 1985
Decision
67d
Days
Class 1
Risk

K850955 is an FDA 510(k) clearance for the ALWAYS MAXIPADS - UNSCENTED. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 67 days - a notably fast clearance 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: 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 K850955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date May 14, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 160d · This submission: 67d
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.

Regulatory Peers - HHD Pad, Menstrual, Unscented

All 53
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K850955.
UNSCENTED ALWAYS PANTILINERS
K852985 · Procter & Gamble Mfg. Co. · Aug 1985
BELIEVE LABIAL PADS
K852226 · Kimberly-Clark Corp. · Aug 1985
ALWAYS SUPER MAXIPAD-UNSCENTED
K850940 · Procter & Gamble Mfg. Co. · May 1985
KOTEX MAXI PADS
K850033 · Kimberly-Clark Corp. · Mar 1985
KOTEX THIN MAXI PADS
K850034 · Kimberly-Clark Corp. · Mar 1985
UNSCENTED MENSTRUAL PAD
K844601 · Procter & Gamble Mfg. Co. · Jan 1985