# K994428: E7512 Premie Rem Polyhesive II Patient Return Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Valleylab, Inc.
- Decided: Mar 7, 2000 after 68 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K813072 (1981). 3 ancestors in all.
11 later devices descend from it; 3 cite it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813072: E2502 & E2502B Lectroswitch, Valleylab, Inc. (1981) Summary page 1.
- K953737: VL7600 Rem Patient Return Electrode, Valleylab, Inc. (1995) Summary page 1.
- K855084: Premie T.D.S. Electrosurgical Grounding Pad, Conmedcorp (1986) Summary page 1.

## Most influential descendants
- K140500: Skintact (2014), 4 descendants of its own
- K080741: Mega Soft Reusable Patient Return Electrode (2008), 4 descendants of its own
- K173877: BOWA Neutral Electrodes (2018), 3 descendants of its own
- K133726: Mega Soft Universal Patient Return Electrode (2014), 3 descendants of its own
- K203494: Nissha Medical Technologies Neutral Electrodes (2021), 1 descendant of its own

## Indications for use
The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. Indications for use are general monopolar electrosurgery on newborn or prematurely born patients of between approximately 1 and 6 lbs.

Source page: https://510kreport.com/device/K994428
Methodology: https://510kreport.com/methodology