# K131866: Sustain

- Pathway: 510(k) (Abbreviated)
- Applicant: Hollender Sustainable Brands, LLC
- Decided: May 1, 2014 after 311 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 K980319 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980319: Durex Ultra Comfort, London Intl., LLC (1998) Summary page 1.
- K980174: Durex Colors and Scents, London Intl., LLC (1998) Summary page 1.

## Indications for use
The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K131866
Methodology: https://510kreport.com/methodology