Cleared Traditional

OBSTETRICAL PAD(STEAM STERILIZED) (K812232) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K812232 · Paper-Pak Products, Inc. · Obstetrics & Gynecology device
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Aug 1981
Decision
14d
Days
Class 1
Risk

K812232 is an FDA 510(k) clearance for the OBSTETRICAL PAD(STEAM STERILIZED). Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Paper-Pak Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 14 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 Paper-Pak Products, Inc. devices

Submission Details

510(k) Number K812232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date August 25, 1981
Days to Decision 14 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
146d faster than avg
Panel avg: 160d · This submission: 14d
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.