# K961502: Lubricating Jelly, Low Viscosity

- Pathway: 510(k) (Traditional)
- Applicant: Span-America Medical Systems, Inc.
- Decided: Jul 18, 1996 after 90 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: 1 generation back to K882506 (1988). 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)
- K882506: Modified American Lubricating Jelly, 2.7 & 5.0, Span-America Medical Systems, Inc. (1988) Summary page 1.

## Indications for use
To lubricaie a budy vrifice to facilitate catry of a diagnostic or therapeutic device.

Source page: https://510kreport.com/device/K961502
Methodology: https://510kreport.com/methodology