# K212304: Callaly Tampliner  (super plus absorbency)

- Pathway: 510(k) (Special)
- Applicant: Calla Lily Personal Care, Ltd.
- Decided: Aug 19, 2021 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K212304
Methodology: https://510kreport.com/methodology