# K203377: VR101 Lubricating Intravaginal Ring

- Pathway: 510(k) (Traditional)
- Applicant: J3 Bioscience, Inc.
- Decided: May 20, 2021 after 184 days
- Product code: QPD (Personal Lubricant Ring)
- 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: 4 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)
- K101241: Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator), Lil Drug Store Products, Inc. (2010) Summary page 6.

## Indications for use
VR101 Lubricating Intravaginal Ring is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex and synthetic (polyurethane and polyisoprene) male condoms and FC2 female condoms.

Source page: https://510kreport.com/device/K203377
Methodology: https://510kreport.com/methodology