# K984488: Sheer Thin

- Pathway: 510(k) (Traditional)
- Applicant: Twe Companies, Inc.
- Decided: Feb 1, 1999 after 46 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912901 (1992). 1 ancestor in all.
1 later device descends 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)
- K912901: Trojan (TM-TBD) Condom, Carter Products (1992) Summary page 1.

## Most influential descendants
- K051273: Divas Dual Pleasure Male Latex Condom (2005), 0 descendants of its own

## Indications for use
The Sheer Thin condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

Source page: https://510kreport.com/device/K984488
Methodology: https://510kreport.com/methodology