Cleared Traditional

Organic cotton tampon, Viscose tampon (K231341) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231341 · Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
97d
Days
Class 2
Risk

K231341 is an FDA 510(k) clearance for the Organic cotton tampon, Viscose tampon. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. (Huzhou, CN). The FDA issued a Cleared decision on August 14, 2023 after a review of 97 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 Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. devices

Submission Details

510(k) Number K231341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2023
Decision Date August 14, 2023
Days to Decision 97 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
63d faster than avg
Panel avg: 160d · This submission: 97d
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

Shenzhen Joyantech Consulting Co., Ltd.
Grace Liu

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 37
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K231341.
TOSAMA Reusable Applicator
K232060 · Tosama, D.O.O. · Apr 2024
Unscented Menstrual Tampon
K232598 · Unibeauty (Hubei) Technology Co., Ltd. · Dec 2023
Daye Tampon
K223883 · Annes Daye, Ltd. · Aug 2023
Sequel Tampon with Plastic Applicator
K230419 · Tampro, Inc. · Aug 2023
U by Kotex® Click® Unscented Menstrual Tampons
K223749 · Kimberly Clark Corporation · Jan 2023
Unscented Menstrual Tampon
K222046 · Suzhou Borage Medical Technology Co., Ltd. · Sep 2022