# K090071: Rostam LTD. Fragranced or Unfragranced New Plastic Applicator Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Rostam, Ltd.
- Decided: May 28, 2009 after 136 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tampax Compak Pearl Scented and unscented Tampons with plastic applicators: named in the summary without a submission number

## Most influential descendants
- K173225: Interlude and private label Unscented 3-piece compact applicator tampon (2018), 2 descendants of its own
- K230419: Sequel Tampon with Plastic Applicator (2023), 0 descendants of its own
- K191431: Interlude Rolled Tampons in Plastic Applicator (2019), 0 descendants of its own

## Indications for use
The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge

Source page: https://510kreport.com/device/K090071
Methodology: https://510kreport.com/methodology