Cleared Traditional

K963032 - FREE CHOICE

K963032 is an FDA 510(k) clearance for FREE CHOICE, manufactured by First Quality Hygienic, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K963032 · First Quality Hygienic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
67d
Days
Class 2
Risk

K963032 is an FDA 510(k) clearance for the FREE CHOICE. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by First Quality Hygienic, Inc. (Allendale, US). The FDA issued a Cleared decision on October 11, 1996 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 884.5470 - 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: 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 First Quality Hygienic, Inc. devices

FDA 510(k) Submission Details - K963032

510(k) Number K963032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date October 11, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
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. 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 136
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K963032.
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
K970232 · Regu-Tech Assoc., Inc. · Mar 1997
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
K965064 · Rostam , Ltd. · Feb 1997
FEMTEX GENTLE TOUCH TAMPONS
K963034 · First Quality Hygienic, Inc. · Nov 1996
YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
K962712 · Talbot S. Lindstrom · Sep 1996
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
SANPOINT MENSTRUAL TAMPON
K961926 · Sanpoint AB · Jul 1996