# K822088: Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Schmid Laboratories, Inc.
- Decided: Nov 3, 1982 after 113 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020659: Durex Latex Condom with Male Genital Desensitizer Lubricant (2002), 2 descendants of its own
- K211152: Durex Condom with Benzocaine (2022), 1 descendant of its own
- K230049: SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K822088
Methodology: https://510kreport.com/methodology