510(k) · Cleared
ClearedPresson Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Persyst Development Corp. · GXZ Electrode, Needle
Cleared on Dec 8, 2011 as substantially equivalent to K022914 (Rhythmlink International, LLC, 2002) after a 414-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.
- Decided
- Dec 8, 2011
- Review
- 414 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K870795 (1987). 20 ancestors in all, the oldest K850107 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 3 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- 2 generations backK990015 Electrode NeedlesTechnomed Europe · 1999
- 1 generation backK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- This deviceK103103 Presson ElectrodePersyst Development Corp. · 2011
- Descendant · cites it directly · 1 of its ownK130220 MR Conditional Presson ElectrodeRhythmlink International, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK190801 PressOn Electrode HeadsetRhythmlink International, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −3 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| −2 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| −1 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| 0 (this device) | K103103 | Presson Electrode | Persyst Development Corp. | 2011 | — |
| +1 | K130220 | MR Conditional Presson Electrode | Rhythmlink International, LLC | 2013 | — |
| +2 | K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
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 GXZ? 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 GXZ device
- #1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K022914 | Rhythmlink International Subdermal Needle ElectrodesSummary page 2…bstantiallyequivalent 510(k) device - Rhythmlink International, LLC Rhythmnlink subdermal K02291 4 Cayce, South Carolina USA needle electrodes Device Description The PressOn electrode is a single-use, disposabl… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130220 | MR Conditional Presson Electrode | 2013 | 1 |
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 9.0 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K130220 (Rhythmlink International, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K022914.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GXZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXZ
102in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXZ
75in 2025
MAUDE reports naming product code GXZ, 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 | 3 | 102 | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 19 | 4 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PressOnTM electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103103: Presson Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103103
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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