# K030474: PH Buffering Plastic Applicator Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Rostam, Ltd.
- Decided: May 28, 2004 after 471 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960341 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960341: Tampax Tampon with Additive Junior,Regular,Super, and Super Plus, Tambrands, Inc. (1996) Summary page 1.
- (no number) Rostam Plastic Applicator Tampons: named in the summary without a submission number

## Indications for use
The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.

Source page: https://510kreport.com/device/K030474
Methodology: https://510kreport.com/methodology