# K051288: Vielle Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Cst Medical Limited
- Decided: Feb 3, 2006 after 261 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: 3 generations back to K903910 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033776: Instead Intimate Lubricant, Instead, Inc. (2004) Summary page 1.
- K041129: Personal Lubricating Gel, Qualis, Inc. (2004) Summary page 1.

## Indications for use
VielleTM personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.

Source page: https://510kreport.com/device/K051288
Methodology: https://510kreport.com/methodology