# K073684: Sheffield Pharmaceuticals (Sterile) Lubrigel

- Pathway: 510(k) (Traditional)
- Applicant: Sheffield Industries, Div. of Faria, Ltd.
- Decided: May 22, 2008 after 146 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974768 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K041060: E-Z Lubricating Jelly, Chester Labs, Inc. (2004) Summary page 4.
- K974768: Pdi Sterile Lubricating Jelly, Nice-Pak Products, Inc. (1998) Summary page 4.

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

## Recalls of this device
- Apr 27, 2015 · Class II · Z-1953-2015: Recovery of high count of gram positive rods including single colonies of B. cepacia.

## Indications for use
Patient lubricant intended for medical purposes to lubricate orifices to facilitate the entry of diagnostic and therapeutic devices. The device is intended for use on order of a physician.

Source page: https://510kreport.com/device/K073684
Methodology: https://510kreport.com/methodology