# K101522: Ultra Seal Sterile Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Ultra Seal Corporation
- Decided: Dec 23, 2010 after 204 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 K974768 (1998). 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)
- K871169: Lubricating Jelly, H & P Industries, Inc. (1987) Summary page 1.
- K073684: Sheffield Pharmaceuticals (Sterile) Lubrigel, Sheffield Industries, Div. of Faria, Ltd. (2008) Summary page 1.

## Indications for use
For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices. The device is intended for use on order of a physician. For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices.

Source page: https://510kreport.com/device/K101522
Methodology: https://510kreport.com/methodology