510(k) Report

510(k) · Cleared

Cleared

Software & Hardware Addition to Sentinel-4 Eeg

K900482510(k) TraditionalCleared Jun 20, 1990139-day reviewClass II21 CFR 882.1870

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

Axon Systems, Inc. · GWF Stimulator, Electrical, Evoked Response

Cleared on Jun 20, 1990 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 466 devices in its family, counting itself, has a Class I recall. 465 later devices descend from it.

Decided
Jun 20, 1990
Review
139 days
Class
Class II
Product code
GWF
Recalls
None
Predicates
0

465 later devices descend from it, 1 citing it directly. 1 of the 466 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared2003: 1 descendant cleared2007: 1 descendant cleared2005: 1 descendant cleared2011: 3 descendants cleared2006: 2 descendants cleared2012: 3 descendants cleared2019: 31 descendants cleared2016: 9 descendants cleared2014: 4 descendants cleared2015: 8 descendants cleared2018: 20 descendants cleared2020: 22 descendants cleared2013: 4 descendants cleared2021: 42 descendants cleared, 1 with a Class I recall12017: 17 descendants cleared2022: 48 descendants cleared2023: 64 descendants cleared2025: 64 descendants cleared2026: 57 descendants cleared2024: 62 descendants cleared1990200020102020
  1. This deviceK900482 Software & Hardware Addition to Sentinel-4 EegAxon Systems, Inc. · 1990
  2. Descendant · cites it directly · 464 of its ownK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
  3. Descendant · 2 generations on · 463 of its ownK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
  4. Descendant · 3 generations on · 462 of its ownK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
  5. Descendant · 4 generations on · 460 of its ownK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
  6. Descendant · 5 generations on · 450 of its ownK061113 OrthomonAxon Systems, Inc. · 2006

Showing 5 of 465 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12003: 12005: 12006: 22007: 12011: 32012: 32013: 42014: 42015: 82016: 92017: 172018: 202019: 312020: 222021: 422022: 482023: 642024: 622025: 642026: 57
1997high 64 (2023) · low 0 (1998)2026

Class I recalls in this family

  • K211616 ExcelsiusHub11 generations on · 2021

Most influential descendants

Showing 5 of 465 · See all
  • K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997 · cites it directly464descendants
  • K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc. · 2002 · 2 generations on463descendants
  • K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003 · 3 generations on462descendants
  • K050798Eclipse Neurological WorkstationAxon Systems, Inc. · 2005 · 4 generations on460descendants
  • K061113OrthomonAxon Systems, Inc. · 2006 · 5 generations on450descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900482Software & Hardware Addition to Sentinel-4 EegAxon Systems, Inc.1990—
+1K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc.1997—
+2K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc.2002—
+3K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc.2003—
+4K050798Eclipse Neurological WorkstationAxon Systems, Inc.2005—
+5K061113OrthomonAxon Systems, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
200510
200620
200710
201130
201230
201340
201440
201580
201690
2017170
2018200
2019310
2020220
2021421
2022480
2023640
2024620
2025640
2026570
FIG. 1 — Lineage of K900482, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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 GWF device

  1. #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (465)

See all 465

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc.1997464

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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 11 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K971819 (Axon Systems, Inc., 1997) has gone furthest, with 464 descendants of its own.

How does its category compare?

All GWF devices

GWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWF

1in 2025

2007: 32008: 22009: 52010: 32011: 22012: 42013: 32014: 12015: 22016: 12017: 32019: 12020: 12021: 22022: 22023: 22024: 42025: 12026 (partial year): 3
2007high 5 (2009) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWF

92in 2024

2007: 69 days median2009: 178 days median2010: 269 days median2012: 230 days median2013: 174 days median2017: 169 days median2024: 92 days median2026 (partial year): 125 days median
2007high 269 (2010) · low 69 (2007)2026

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

Recalls per year · GWF

2so far in 2026, the most since 2007

2012: 12015: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

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

Adverse event reports per year · GWF

1,034in 2025

2007: 22008: 12009: 12010: 42011: 102012: 442013: 892014: 252015: 222016: 202017: 602018: 582019: 942020: 652021: 552022: 452023: 1502024: 8542025: 1,034
2007high 1,034 (2025) · low 1 (2008)2025

MAUDE reports naming product code GWF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200736902
20082—01
2009517801
2010326904
20112—010
20124230144
20133174089
20141—025
20152—122
20161—020
20173169060
20180—058
20191—094
20201—065
20212—055
20222—045
20232—0150
20244920854
20251—01,034
202631252—

More from Axon Systems, Inc.

15 FDA decisions under this applicant name. See the company

  • K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
  • K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
  • K062198Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006
  • K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler…Axon Systems, Inc. · 2006
  • K061113OrthomonAxon Systems, Inc. · 2006

Recent decisions in GWF

The GWF category page

  • K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH · 2026
  • K253301BraiN20® (BraiN20)Time IS Brain, S.L. · 2026
  • K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · 20261 recall
  • K243982Nicolet EDXNatus Neurology Incorporated · 2025
  • K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated · 2024

https://510kreport.com/device/K900482 · printed Nov 3, 2026

Cite this page

510(k) Report. “K900482: Software & Hardware Addition to Sentinel-4 Eeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K900482

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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