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Unscented Menstrual Tampon

by Bnt Co, Inc.

510(k) K832818

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832818 Date17 Jan 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HEB
Device Class
Class II
Regulation
21 CFR Part 884.5470
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Unscented Menstrual Tampon is a Class II medical device classified as a vaginal plug designed to absorb menstrual or vaginal discharge. It is constructed from cellulosic or synthetic material and is intended for insertion into the vagina to provide comfort and hygiene during menstruation or other vaginal discharge.

This device is supplied as a single-use product and is regulated under 21 CFR 884.5470. It received FDA 510(k) clearance (K832818) in 1984 through a traditional review process, with the Obstetrics/Gynecology advisory committee overseeing its submission. No third-party review was involved, and the product is identified by the FDA product code HEB.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Unscented Menstrual Tampon designed for?

    The Unscented Menstrual Tampon is a Class II medical device designed as a vaginal plug to absorb menstrual or vaginal discharge. It is intended for insertion into the vagina to provide comfort and maintain hygiene during menstruation or other vaginal discharge situations. The device is constructed from cellulosic or synthetic materials, ensuring it is gentle and suitable for internal use.

  • Is the Unscented Menstrual Tampon single-use or reusable?

    The Unscented Menstrual Tampon is supplied as a single-use product. This design ensures hygiene and safety, as each tampon is intended for one-time use only, reducing the risk of infection or irritation from reuse.

  • What materials is the Unscented Menstrual Tampon made from?

    The tampon is constructed from either cellulosic or synthetic materials. These materials are chosen for their ability to absorb menstrual or vaginal discharge effectively while maintaining comfort and safety for the user.

  • How is the Unscented Menstrual Tampon regulated?

    The Unscented Menstrual Tampon is regulated under 21 CFR 884.5470 and received FDA 510(k) clearance (K832818) in 1984. The submission was reviewed by the Obstetrics/Gynecology advisory committee and determined to be substantially equivalent to a predicate device through a traditional review process. The product is classified under the FDA product code HEB.

  • Are there different sizes or models available for the Unscented Menstrual Tampon?

    Multiple models and registration numbers are associated with the Unscented Menstrual Tampon, as indicated by the FDA registration numbers (e.g., 3016010004, 3038182652, etc.). These variations may correspond to different sizes or slight modifications in design, but the core function and material composition remain consistent across all versions. For specific sizing details, refer to the product packaging or manufacturer’s documentation.