Cleared Abbreviated

K151470 - Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency (FDA 510(k) Clearance)

Also includes:
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K151470 · First Quality Hygienic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
154d
Days
Class 2
Risk

K151470 is an FDA 510(k) clearance for the Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light A.... Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by First Quality Hygienic, Inc. (Mcelhattan, US). The FDA issued a Cleared decision on November 2, 2015 after a review of 154 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all First Quality Hygienic, Inc. devices

Submission Details

510(k) Number K151470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date November 02, 2015
Days to Decision 154 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 160d · This submission: 154d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

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 188
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K151470.
Livi Device
K252005 · Liviwell, Inc. · Mar 2026
Unscented Menstrual Long Applicator Tampon
K253719 · Unibeauty (Hubei) Technology Co., Ltd. · Dec 2025
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K252939 · Cotton High Tech S.L. · Oct 2025
Unscented menstrual three-piece applicator tampon
K252613 · Unibeauty (Hubei) Technology Co., Ltd. · Sep 2025
Unscented menstrual long applicator tampon
K251033 · Unibeauty (Hubei) Technology Co., Ltd. · Aug 2025
SABA Tampons
K242105 · Essity Higiene Y Salud Mexico. S.A. DE C.V. · Apr 2025