510(k) · Cleared

Cleared

Pro-Tech Delivery System Electrodes, Model TT-2000

K081279510(k) TraditionalCleared Jan 23, 2009262-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

Transfer Technology · GXY Electrode, Cutaneous

Cleared on Jan 23, 2009 as substantially equivalent to K000870 (Katecho, Inc., 2000) and 2 other predicates after a 262-day review. Its family tree reaches back 1 generation to 1988.

Decided: Jan 23, 2009
Review: 262 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K875284 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK875284 Medtronic Snap Ease Model 7795 Cutaneous ElectrodeMedtronic Vascular · 1988
This deviceK081279 Pro-Tech Delivery System Electrodes, Model TT-2000Transfer Technology · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K875284	Medtronic Snap Ease Model 7795 Cutaneous Electrode	Medtronic Vascular	1988	—
0 (this device)	K081279	Pro-Tech Delivery System Electrodes, Model TT-2000	Transfer Technology	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

FIG. 1 — Lineage of K081279, 1988–2009Source: 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
*	K000870	KM-10 Tens Electrode Summary page 1 …PRO-TECH Delivery System Electrodes Common Name Neurostimulation Electrodes Classification Name Electrodes, Cutaneous Predicate Device K000870 (Katecho Inc) K970426 (Axelgaard Manufactuning) K875284 (Medtronic Inc) Des…	Katecho, Inc.	2000	—
*	K970426	Valuetrode Summary page 1 …Neurostimulation Electrodes Classification Name Electrodes, Cutaneous Predicate Device K000870 (Katecho Inc) K970426 (Axelgaard Manufactuning) K875284 (Medtronic Inc) Descnption of Device Electrodes, Cutaneous Int…	Axelgaard Mfg. Co., Ltd.	1997	—
*	K875284	Medtronic Snap Ease Model 7795 Cutaneous Electrode Summary page 1 …ame Electrodes, Cutaneous Predicate Device K000870 (Katecho Inc) K970426 (Axelgaard Manufactuning) K875284 (Medtronic Inc) Descnption of Device Electrodes, Cutaneous Intended Use The Transfer Technology PRO-TECH Deli…	Medtronic Vascular	1988	—
†	K983741	Everlast Neurostimulation Electrodes 2X 2,Model # EL2020	Axelgaard Mfg. Co., Ltd.	1998	—

Also cleared against K000870: 1 other device →

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.
1 other device also cites its predicate K000870.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Transfer Technology PRO-TECH Delivery System electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator Transfer Technology's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, ie TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), and MANS (Muscle and Neurological Stimulators)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081279 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081279: Pro-Tech Delivery System Electrodes, Model TT-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081279

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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