510(k) · Cleared
ClearedAgram Spyral Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agram Export-Import Co. · GXZ Electrode, Needle
Cleared on Mar 14, 1995 after a 524-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Mar 14, 1995
- Review
- 524 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK934779 Agram Spyral ElectrodeAgram Export-Import Co. · 1995
- Descendant · cites it directly · 13 of its ownK050194 Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK073229 Nerve Monitoring CablePioneer Surgical Technology · 2008
- Descendant · 2 generations on · 5 of its ownK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 4 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K050194Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc. · 2005 · cites it directly13descendants
- K073229Nerve Monitoring CablePioneer Surgical Technology · 2008 · 2 generations on5descendants
- K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008 · 2 generations on5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 3 generations on4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934779 | Agram Spyral Electrode | Agram Export-Import Co. | 1995 | — |
| +1 | K050194 | Axon Systems Subdermal Needle Electrodes | Axon Systems, Inc. | 2005 | — |
| +2 | K073229 | Nerve Monitoring Cable | Pioneer Surgical Technology | 2008 | — |
| +2 | K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | 2008 | — |
| +3 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +4 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050194 | Axon Systems Subdermal Needle Electrodes | 2005 | 13 |
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?
- Of its descendants, K050194 (Axon Systems, Inc., 2005) has gone furthest, with 13 descendants of its own.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K934779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934779: Agram Spyral Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934779
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026