# K042773: Rostam Scented and Unscented Plastic Applicator Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Rostam, Ltd.
- Decided: Nov 23, 2004 after 49 days
- Product code: HIL ( Tampon, Menstrual, Scented, Scented-Deodorized)
- Device class: 2
- Regulation: 21 CFR 884.5460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Rostam Scented and unscented Tampons with plastic applicators: named in the summary without a submission number

## Most influential descendants
- K140077: Albaad Plastic Applicator Tampons Unscented (2014), 0 descendants of its own
- K102445: Rostam Scented and Unscented Biodegradable Plastic Applicator Tampons (2010), 0 descendants of its own

## Indications for use
As a Class II Device, the menstrual tampon is defined as follows: (21 CFR 884.5400 and 21 CFR 884 5470). Rostam Ltd. Fragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K042773
Methodology: https://510kreport.com/methodology