# K970581: Clinijel

- Pathway: 510(k) (Traditional)
- Applicant: Hospicon Products
- Decided: Sep 3, 1997 after 201 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 K871169 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871169: Lubricating Jelly, H & P Industries, Inc. (1987) Summary page 1.
- (no number) H R Lubricating Jelly: named in the summary without a submission number
- (no number) K-Y Jelly: named in the summary without a submission number

## Indications for use
Clinijel is specially formulated to provide vaginal moisture, lubricate condoms, and help ease insertion of tampons, rectal thermometers, enema and douche nozzles.

Source page: https://510kreport.com/device/K970581
Methodology: https://510kreport.com/methodology