510(k) · Cleared

Cleared

Frems SSC Disposable Foam Electrodes, Model 800-000-057; Frems SSC Disposable Non-Woven Electrodes, Model 800-000-058

K080902510(k) AbbreviatedCleared Jun 13, 200872-day reviewClass II21 CFR 882.1320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lorenz Biotech S.P.A. · GXY Electrode, Cutaneous

Cleared on Jun 13, 2008 as substantially equivalent to K831785 (Andover Medical, Inc., 1983) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1982.

Decided: Jun 13, 2008
Review: 72 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K822224 (1982). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK822224 Empi Single UseEmpi · 1982
This deviceK080902 Frems SSC Disposable Foam Electrodes, Model 800-000-057; Frems SSC…Lorenz Biotech S.P.A. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K822224	Empi Single Use	Empi	1982	—
0 (this device)	K080902	Frems SSC Disposable Foam Electrodes, Model 800-000-057; Frems SSC Disposable…	Lorenz Biotech S.P.A.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	1	0

FIG. 1 — Lineage of K080902, 1982–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in GXY? 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 GXY device

#1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K831785	Neuro Ease Summary page 1 …Common/Usual Name: Cutaneous stimulation electrodes Classification Name: Cutaneous electrodes 3. PREDICATE DEVICES · NeuroEase (K831785, Andover Medical Inc.; currently shown as being manufactured and listed by Empi) * Snap Ease (K822224, K8…	Andover Medical, Inc.	1983	—
*	K822224	Empi Single Use Summary page 1 …PREDICATE DEVICES · NeuroEase (K831785, Andover Medical Inc.; currently shown as being manufactured and listed by Empi) * Snap Ease (K822224, K854513, Empi; currently shown as being manufactured and listed by Emnpi) 4. DEVICE DESCRIPTION The Lorenz…	Empi	1982	—
*	K854513	Empi, NMS/Sue Cutaneous Electrode Summary page 1 …E DEVICES · NeuroEase (K831785, Andover Medical Inc.; currently shown as being manufactured and listed by Empi) * Snap Ease (K822224, K854513, Empi; currently shown as being manufactured and listed by Emnpi) 4. DEVICE DESCRIPTION The Lorenz Biotech…	Empi	1985	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GXY

6in 2025

2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007high 203 (2014) · low 81 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXY

2in 2023

2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXY

58in 2025

2007high 58 (2025) · low 10 (2018)2025

MAUDE reports naming product code GXY, 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	7	88	0	14
2008	9	136	0	17
2009	17	159	4	15
2010	3	137	1	14
2011	6	183	5	16
2012	9	150	4	16
2013	7	99	0	15
2014	9	203	0	11
2015	6	119	0	19
2016	6	170	0	15
2017	9	116	0	11
2018	14	135	0	10
2019	9	113	0	19
2020	4	108	0	11
2021	12	195	0	21
2022	5	81	0	34
2023	13	132	2	25
2024	7	111	0	51
2025	6	148	0	58
2026	12	70	0	—

What is it indicated for?

The Lorenz Biotech S.p.A. FREMS SSC Disposable (Foam and Non-Woven) Electrodes are accessories to the Lorenz Biotech Aptiva and are intended to be used for electrical stimulation. They are non-sterile and for single patient use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080902 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080902: Frems SSC Disposable Foam Electrodes, Model 800-000-057; Frems SSC Disposable Non-Woven Electrodes, Model 800-000-058.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080902

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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