510(k) · Cleared
ClearedMicroelectroencephalography Professional System 5000 (Eeg Pro System 5000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microrecording Systems Consultants, LLC · GZL Electrode, Depth
Cleared on Jun 9, 1999 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 22 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it.
- Decided
- Jun 9, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 4 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- This deviceK991077 Microelectroencephalography Professional System 5000 (Eeg Pro System…Microrecording Systems Consultants, LLC · 1999
- Descendant · cites it directly · 17 of its ownK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- Descendant · cites it directly · 16 of its ownK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- Descendant · 2 generations on · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- Descendant · 3 generations on · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · cites it directly · 6 of its ownK012850 Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 2001
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K011775 Micro Targeting Drive Systemcites it directly · 2001
Most influential descendants
Showing 5 of 21 · See all- K991522Microtargeting ElectrodeFHC, Inc. · 2000 · cites it directly17descendants
- K033173Micro Targeting ElectrodeFHC, Inc. · 2004 · cites it directly16descendants
- K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004 · 2 generations on12descendants
- K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp · 2006 · 3 generations on11descendants
- K012850Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 2001 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991077 | Microelectroencephalography Professional System 5000 (Eeg Pro System 5000) | Microrecording Systems Consultants, LLC | 1999 | — |
| +1 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| +1 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| +2 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| +3 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| +1 | K012850 | Recording and Stimulating Electrode | Radionics, A Division of Tyco Healthcare Group LP | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 1 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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 GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K011775Micro Targeting Drive SystemFHC, Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991522 (FHC, Inc., 2000) has gone furthest, with 17 descendants of its own.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, 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 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of our uEEG™ Pro System 5000 is for temporary recording of intracranial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials. Our uEEG™ Pro System 5000 is intended to be used during neurosurgical procedures for an amount of time that is sufficient to obtain the necessary information. During recording procedures, the required time duration is between 30 minutes to several…
Read the full statement (161 words)
The intended use of our uEEG™ Pro System 5000 is for temporary recording of intracranial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials.
Our uEEG™ Pro System 5000 is intended to be used during neurosurgical procedures for an amount of time that is sufficient to obtain the necessary information. During recording procedures, the required time duration is between 30 minutes to several hours. During this time, an electrode will be in continuous contact with tissue for no longer than about 30 minutes.
The uEEG™ Pro System 5000 is designed for use in operating rooms appropriate for functional neurosurgery. (Warning Labels are attached to machine indicating that it is not to be used in the presence of flammable anesthetics).
uEEG™ Pro System 5000 is indicated for use during intraoperative intracranial neurophysiological recording and stimulation during deep brain stimulation, epilepsy surgery, and other procedures where it is appropriate to perform intracranial depth or subdural electrode recordings.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991077: Microelectroencephalography Professional System 5000 (Eeg Pro System 5000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991077
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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