# K852956: Contact Conductive Adhesive Gel Composition

- Pathway: 510(k) (Traditional)
- Applicant: Parker Laboratories, Inc.
- Decided: Aug 9, 1985 after 29 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K030887: Lektrogel, Model LK3001 (2003), 0 descendants of its own

## Recalls of this device
- Feb 7, 2024 · Class II · Z-1305-2024: Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They ha
- Feb 7, 2024 · Class II · Z-1306-2024: Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They ha
- Jan 22, 2024 · Class II · Z-1204-2024: Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.

Source page: https://510kreport.com/device/K852956
Methodology: https://510kreport.com/methodology
