Cleared Special

K192557 - Youjia Unscented Tampon with Plastic Applicators

K192557 is an FDA 510(k) clearance for Youjia Unscented Tampon with Plastic Ap..., manufactured by Qingdao Youjia Hygiene Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Special 510(k) pathway after a 149-day FDA review.

K192557 · Qingdao Youjia Hygiene Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
149d
Days
Class 2
Risk

K192557 is an FDA 510(k) clearance for the Youjia Unscented Tampon with Plastic Applicators. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Qingdao Youjia Hygiene Technology Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on February 13, 2020 after a review of 149 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192557

510(k) Number K192557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date February 13, 2020
Days to Decision 149 days
Submission Type Special
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
12d faster than avg
Panel avg: 161d · This submission: 149d
Pathway characteristics
Modification to existing cleared device.

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

Suzhou Jiuzhen Consulting Company , Ltd.
Emma Xing

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 188
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K192557 · Youjia Unscented Tampon with Plastic Applicators
Download PDF FDA Summary Qingdao Youjia Hygien…