Cleared Traditional

K912552 - UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR

K912552 is an FDA 510(k) clearance for UNSCENTED MENSTRUAL TAMPON W/A MODIFIED..., manufactured by Personal Products Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K912552 · Personal Products Co. · Obstetrics & Gynecology device
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Sep 1991
Decision
105d
Days
Class 2
Risk

K912552 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on September 24, 1991 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5470 - 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 Personal Products Co. devices

FDA 510(k) Submission Details - K912552

510(k) Number K912552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1991
Decision Date September 24, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 160d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

Product Code HEB Tampon, Menstrual, Unscented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5470
Definition An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.
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 - HEB Tampon, Menstrual, Unscented

All 153
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K912552.
TAMPAX TAMPONS, SUPER ABSORBENCY
K923932 · Tambrands, Inc. · Jul 1993
TAMPAX TAMPON, REGULAR ABSORBENCY
K924303 · Tambrands, Inc. · Jul 1993
UNSCENTED MENSTRUAL TAMPON
K923985 · Personal Products Co. · Feb 1993
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
K904937 · Playtex Family Products, Inc. · Mar 1991
UNSCENTED MENSTRUAL TAMPON
K897007 · Personal Products Co. · Jul 1990
MENSTRUAL TAMPON
K897008 · Personal Products Co. · Jan 1990