# K021125: Sensua!

- Pathway: 510(k) (Traditional)
- Applicant: Aac Consulting Group, Inc.
- Decided: Oct 25, 2002 after 200 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: 2 generations back to K810310 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983216: CVS Personal Lubricant, San-Mar Laboratories, Inc. (1999) Summary page 1.
- K935299: Astroglide, Biofilm, Inc. (1994) Summary page 1.
- K001077: Lubrigel Personal Lubricant, Sheffield Laboratories, Div. of Faria Limited, LLC (2000) Summary page 1.

## Indications for use
Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.

Source page: https://510kreport.com/device/K021125
Methodology: https://510kreport.com/methodology