# K974768: Pdi Sterile Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Nice-Pak Products, Inc.
- Decided: Jan 16, 1998 after 25 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073684: Sheffield Pharmaceuticals (Sterile) Lubrigel (2008), 1 descendant of its own
- K131617: Colonglide (R) Lubricant (2013), 0 descendants of its own
- K101522: Ultra Seal Sterile Lubricating Jelly (2010), 0 descendants of its own

## Indications for use
PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as a catheter, enema tip, or endoscope). The device is intended for use on order of a physician.

Source page: https://510kreport.com/device/K974768
Methodology: https://510kreport.com/methodology