# K973557: Lubriglide

- Pathway: 510(k) (Traditional)
- Applicant: Qualis, Inc.
- Decided: Oct 10, 1997 after 21 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- 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). 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)
- K935299: Astroglide, Biofilm, Inc. (1994) Summary page 1.

## Indications for use
Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.

Source page: https://510kreport.com/device/K973557
Methodology: https://510kreport.com/methodology