Identifiers
- 510(k) Number
- K212277 FDA 510(k)
- FDA Product Code
- HEB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5470 FDA 510(k)
- Regulation Number
- 884.5470 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tempo Tampon is a menstrual tampon, classified as a Class 2 device under the product code HEB, used in obstetrics and gynecology. It is designed to absorb menstrual flow.
The Tempo Tampon is supplied as a single-use device, and its use is intended for menstrual hygiene. The device has been cleared through the Traditional 510(k) pathway and has received FDA 510(k) clearance, with the regulation number 884.5470. It is manufactured by Dong-A Pharmaceutical Co., Ltd.
Frequently asked questions
What is the Tempo Tampon used for?
The Tempo Tampon is used for menstrual hygiene, designed to absorb menstrual flow.
Is the Tempo Tampon a single-use device?
Yes, the Tempo Tampon is supplied as a single-use device.
What regulatory pathway was used for clearance?
The Tempo Tampon was cleared through the Traditional 510(k) pathway with the regulation number 884.5470.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K212277 FDA 510 (k) - Tempo Tampon, Brand : Our Brands : Brand Details, Dong-A Pharmaceutical's Tempo Tampon Plant Wins GMP Certification, Dong-A Pharmaceutical wins GMP nod for Tempo tampon plant in South ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212277 | Class II | Active |
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Manufacturer
- Manufacturer
- Dong-A Pharmaceutical Co., Ltd.
Sources (1)
- FDA 510(k) K212277 24 fields · synced Sep 27, 2026