510(k) · Cleared
ClearedE7512 Premie Rem Polyhesive II Patient Return Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 7, 2000 as substantially equivalent to K813072 (Valleylab, Inc., 1981) and 2 other predicates after a 68-day review. Its family tree reaches back 1 generation to 1981. 3 of the 15 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Mar 7, 2000
- Review
- 68 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K813072 (1981). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK813072 E2502 & E2502B LectroswitchValleylab, Inc. · 1981
- This deviceK994428 E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK140500 SkintactLeonhard Lang GmbH · 2014
- Descendant · cites it directly · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
- Descendant · 2 generations on · 3 of its ownK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK203494 Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K140500SkintactLeonhard Lang GmbH · 2014 · cites it directly4descendants
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · cites it directly4descendants
- K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018 · 2 generations on3descendants
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 2 generations on3descendants
- K203494Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813072 | E2502 & E2502B Lectroswitch | Valleylab, Inc. | 1981 | — |
| 0 (this device) | K994428 | E7512 Premie Rem Polyhesive II Patient Return Electrode | Valleylab, Inc. | 2000 | — |
| +1 | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| +1 | K080741 | Mega Soft Reusable Patient Return Electrode | Megadyne Medical Products, Inc. | 2008 | Class I |
| +2 | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
| +2 | K133726 | Mega Soft Universal Patient Return Electrode | Megadyne Medical Products, Inc. | 2014 | Class I |
| +3 | K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2014 | 2 | 1 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K813072 | E2502 & E2502B LectroswitchSummary page 1…Name: Patient Return Electrode Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories Predicate Devices Valleylab E7507 Return Electrode (K813072) Valleylab VL7600 Return Electrode (K953737) ConMed 440-2400 MacrolLyte® Premie Dispersive Electrode (K855084) Device Descriptio… | 1981 |
| * | K953737 | VL7600 Rem Patient Return ElectrodeSummary page 1…on Name: Electrosurgical Cutting and Coagulation Device and Accessories Predicate Devices Valleylab E7507 Return Electrode (K813072) Valleylab VL7600 Return Electrode (K953737) ConMed 440-2400 MacrolLyte® Premie Dispersive Electrode (K855084) Device Description The E7512 Neonatal REM PolyHesive™ |l Neon… | 1995 |
| * | K855084 | Premie T.D.S. Electrosurgical Grounding PadSummary page 1…ories Predicate Devices Valleylab E7507 Return Electrode (K813072) Valleylab VL7600 Return Electrode (K953737) ConMed 440-2400 MacrolLyte® Premie Dispersive Electrode (K855084) Device Description The E7512 Neonatal REM PolyHesive™ |l Neonatal Patient Return Electrode is a single use, non-sterile dispers… | 1986 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K140500 (Leonhard Lang GmbH, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994428: E7512 Premie Rem Polyhesive II Patient Return Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994428
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026