Cleared Traditional

K191431 - Interlude Rolled Tampons in Plastic App...

K191431 is the FDA 510(k) clearance for Interlude Rolled Tampons in Plastic App... by Albaad Fem. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K191431 · Albaad Fem · Obstetrics & Gynecology device
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Oct 2019
Decision
131d
Days
Class 2
Risk

K191431 is an FDA 510(k) clearance for the Interlude Rolled Tampons in Plastic Applicator. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Albaad Fem (Caesarea Ind. Park, IL). The FDA issued a Cleared decision on October 7, 2019 after a review of 131 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 Albaad Fem devices

Submission Details

510(k) Number K191431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2019
Decision Date October 07, 2019
Days to Decision 131 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
29d faster than avg
Panel avg: 160d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Regulatory Technical Associates
Robert. J. Staab

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 99
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K191431.
Callaly Tampliner
K201003 · Calla Lily Personal Care, Ltd. · Dec 2020
Youjia Unscented Tampon with Plastic Applicators
K192557 · Qingdao Youjia Hygiene Technology Co., Ltd. · Feb 2020
Unscented W long plastic and cardboard applicator tampons
K191666 · Ontex Bvba · Dec 2019
FEMME Applicator Tampon
K182142 · Jiangsu Yoai Technology Co., Ltd. · Aug 2019
CottonDay Tampon
K182817 · Taebong Co., Ltd. · Jul 2019
Rael Tampon
K182814 · Rael, Inc. · Jul 2019