Cleared Traditional

K820522 - CAREFREE PANTY SHIELDS

K820522 is an FDA 510(k) clearance for CAREFREE PANTY SHIELDS, manufactured by Personal Products Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K820522 · Personal Products Co. · Obstetrics & Gynecology device
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Mar 1982
Decision
10d
Days
Class 1
Risk

K820522 is an FDA 510(k) clearance for the CAREFREE PANTY SHIELDS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Personal Products Co. (Walker, US). The FDA issued a Cleared decision on March 8, 1982 after a review of 10 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.

FDA 510(k) Submission Details - K820522

510(k) Number K820522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1982
Decision Date March 08, 1982
Days to Decision 10 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
151d faster than avg
Panel avg: 161d · This submission: 10d
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 135
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K820522.
GARDS (UNSCENTED, MENSTRUAL PAD)
K822433 · Hospital Specialty Co. · Aug 1982
REGULAR MAXITHINS PADS & SUPER MAXITHINS
K821800 · Tampax, Inc. · Jun 1982
MAXI & MINI SHIELDS
K820960 · Dafoe & Dafoe, Inc. · May 1982
MAXI SHIELDS MENSTRUAL PADS
K820287 · I.C.D. Industries, Inc. · Mar 1982
MINI SHIELDS MENSTRUAL PADS
K820288 · I.C.D. Industries, Inc. · Mar 1982
UNSCENTED MENSTRUAL PADS-MAXI PADS
K813251 · I.C.D. Industries, Inc. · Dec 1981
K820522 · CAREFREE PANTY SHIELDS
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