Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)
FDA 510(k) K051290 · Procter & Gamble Co.
510(k) numberK051290
Submission
- Device name
- Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)
- Applicant
- Procter & Gamble Co.
Cincinnati, OH, US - Received
- May 18, 2005
- Decision date
- December 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEB – Tampon, Menstrual, Unscented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5470
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code HEB
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|---|---|---|---|
| K252005 | Livi DeviceHEB · Traditional | Liviwell, Inc. | 03/20/2026SE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 12/17/2025SE |
| K252939 | Cohitech Organic Cotton Compact Applicator TamponsHEB · Special | Cotton High Tech S.L. | 10/09/2025SE |
| K252613 | Unscented menstrual three-piece applicator tamponHEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 09/19/2025SE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 08/13/2025SE |
| K242105 | SABA TamponsHEB · Traditional | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 04/01/2025SE |
| K241064 | Unscented TamponHEB · Traditional | Shandong Intco Hygiene Products Co., Ltd. | 01/10/2025SE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional | Suzhou Borage Medical Technology Co., Ltd. | 05/10/2024SE |
| K232060 | TOSAMA Reusable ApplicatorHEB · Traditional | Tosama, D.O.O. | 04/12/2024SE |
| K232598 | Unscented Menstrual TamponHEB · Traditional | Unibeauty (Hubei) Technology Co., Ltd. | 12/15/2023SE |
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| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 09/02/2020SE |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional | 08/27/2020SE |
| K151413 | Always/Tampax bladder supportsHHW · Traditional | 12/18/2015SE |
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional | 09/15/2014SE |
| K133244 | Tampax M Plastic Tampons, UnscentedHEB · Special | 01/09/2014SE |
| K131543 | Tampax(R) L Plastic Tampons, UnscentedHEB · Special | 06/20/2013SE |
| K113699 | Tampax(R) V Plastic Applicator Tampons, UnscentedHEB · Special | 01/12/2012SE |
| K110669 | Tampax C Plastic Tampons, UnscentedHEB · Special | 06/02/2011SE |
| K091281 | Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl…HEB · Traditional | 06/01/2010SE |
Questions and answers
When was Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented) cleared by the FDA?
Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented) (K051290) received a 510(k) decision of Substantially Equivalent on December 27, 2005, 223 days after the submission was received.
What is the product code of K051290?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.