# K982673: Just Between US, Personal Lubricant & Condom

- Pathway: 510(k) (Traditional)
- Applicant: Key West Fragrance & Cosmetic
- Decided: Oct 29, 1998 after 90 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 K903910 (1990). 2 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K903910: Lubricating Jelly, Lake Pharmaceutical, Inc. (1990) Summary page 1.

## Most influential descendants
- K033776: Instead Intimate Lubricant (2004), 17 descendants of its own
- K051295: I-D Glide (2006), 15 descendants of its own
- K150480: JO H20 Water Based Personal Lubricant (2015), 12 descendants of its own
- K160211: Wet Original Personal Lubricant (2016), 9 descendants of its own
- K183384: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant (2019), 6 descendants of its own

## Indications for use
The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.

Source page: https://510kreport.com/device/K982673
Methodology: https://510kreport.com/methodology
