Cleared Abbreviated

K151470 - Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency

Also marketed or referenced as:
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

K151470 is an FDA 510(k) clearance for Opal by Femtex and Private Label Unscen..., manufactured by First Quality Hygienic, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Abbreviated 510(k) pathway after a 154-day FDA review.

K151470 · First Quality Hygienic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K151470

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 161d · This submission: 154d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEB Tampon, Menstrual, Unscented

All 179
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K151470.
Ontex and other proprietary names
K162746 · Ontex Bvba · Mar 2017
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
K161877 · First Quality Hygienic, Inc. · Aug 2016
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS
K152284 · Cotton High Tech S.L. · Dec 2015
Tosama 100% Organic Cotton Menstrual Tampon
K151170 · Tosama, D.O.O. · Jul 2015
Ontex Unscented Tampons with Colored Plastic Applicators
K142786 · Ontex Bvba · Jun 2015
Tosama 100% Cotton Menstrual Tampon
K150897 · Tosama, D.O.O. · Apr 2015

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K151470 · Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency
Download PDF FDA Summary First Quality Hygieni…