# K131617: Colonglide (R) Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Pediatric Pharmaceuticals, Inc.
- Decided: Oct 3, 2013 after 122 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 K951431 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974768: Pdi Sterile Lubricating Jelly, Nice-Pak Products, Inc. (1998) Summary page 1.
- K951431: Aquagel Lubricating Jelly, Depuy Healthcare (1995) Summary page 1.

## Indications for use
The Colonglideo Lubricant Isindicated for medical purposes for use to lubricate a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as an endloscope). This device is Intended for use on order of a physician.

Source page: https://510kreport.com/device/K131617
Methodology: https://510kreport.com/methodology