# K212277: Tempo Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Dong-A Pharmaceutical Co., Ltd.
- Decided: Apr 21, 2022 after 275 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: 6 generations back to K040999 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182817: CottonDay Tampon, Taebong Co., Ltd. (2019) Summary page 4.

## Indications for use
The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K212277
Methodology: https://510kreport.com/methodology