# K951431: Aquagel Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Healthcare
- Decided: Jul 21, 1995 after 116 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K131617: Colonglide (R) Lubricant (2013), 0 descendants of its own
- K091298: Lubrease Female Lubricant (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K951431
Methodology: https://510kreport.com/methodology