# K871169: Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: H & P Industries, Inc.
- Decided: Apr 1, 1987 after 8 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101522: Ultra Seal Sterile Lubricating Jelly (2010), 0 descendants of its own
- K970581: Clinijel (1997), 0 descendants of its own

## Recalls of this device
- Feb 7, 2011 · Not classified · Z-2013-2011: Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.
- Dec 23, 2010 · Not classified · Z-0934-2011: Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the v

Source page: https://510kreport.com/device/K871169
Methodology: https://510kreport.com/methodology