Cleared Traditional

MENSTRUAL PADS (K834564) - FDA 510(k) Clearance

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

K834564 · Probel-U.S., Inc. · Obstetrics & Gynecology device
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Mar 1984
Decision
93d
Days
Class 2
Risk

K834564 is an FDA 510(k) clearance for the MENSTRUAL PADS. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Probel-U.S., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 93 days - within the typical 510(k) review window.

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: 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 Probel-U.S., Inc. devices

Submission Details

510(k) Number K834564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1983
Decision Date March 30, 1984
Days to Decision 93 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
67d faster than avg
Panel avg: 160d · This submission: 93d
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.

Regulatory Peers - HHL Pad, Menstrual, Scented, Scented-deodorized

All 56
Devices cleared under the same product code (HHL) and FDA review panel - the closest regulatory comparables to K834564.
SURE & NATURAL DEODORANT MAXI-SHIELD
K843155 · Johnson & Johnson Professionals, Inc. · Aug 1984
STAYFREE* DEODORANT MAXI-PADS
K834302 · Johnson & Johnson Professionals, Inc. · Jan 1984
CAREFREE * PANTY SHIELDS-REG/DEOR
K832382 · Johnson & Johnson Professionals, Inc. · Aug 1983
PETITES BETWEEN-PERIOD PROTECTORS
K771547 · 3M Company · Sep 1977