# K971303: Instead, Softcup

- Pathway: 510(k) (Traditional)
- Applicant: Ultrafem, Inc.
- Decided: Jun 6, 1997 after 59 days
- Product code: HHE (Cup, Menstrual)
- Device class: 2
- Regulation: 21 CFR 884.5400
- 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; 1 cites 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083769: Modification to Uresta Pessary (2009), 1 descendant of its own
- K232525: Yoni.Fit Bladder Support (2024), 0 descendants of its own

## Indications for use
For use as a form of feminine protection, commonly employed to collect blood, help prevent leakage and to prevent staining and spotting of clothing.

Source page: https://510kreport.com/device/K971303
Methodology: https://510kreport.com/methodology