510(k) · Cleared
ClearedSatellite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 25, 1997 as substantially equivalent to K946094 (Cadwell Laboratories, Inc., 1995) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 25, 1997
- Review
- 76 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946094 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946094 Cadwell Easy Ambulatory EegCadwell Laboratories, Inc. · 1995
- This deviceK971331 SatelliteNicolet Biomedical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946094 | Cadwell Easy Ambulatory Eeg | Cadwell Laboratories, Inc. | 1995 | — |
| 0 (this device) | K971331 | Satellite | Nicolet Biomedical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K946094 | Cadwell Easy Ambulatory EegSummary page 2…fication name: Electroencephalograph (84GWQ) (3) Identification of the legally marketed devices to which equivalence is claimed. 1. Cadwell Easy Ambulatory (FDA Log No. K946094). 2. Bio-Logic Ceegraph Traveler (FDA Log No. K954954). (4) Description of the device, including an explanation of how the devic… | 1995 |
| * | K954954 | Ceegraph Traveler Ambulatory Eeg RecorderSummary page 2…tification of the legally marketed devices to which equivalence is claimed. 1. Cadwell Easy Ambulatory (FDA Log No. K946094). 2. Bio-Logic Ceegraph Traveler (FDA Log No. K954954). (4) Description of the device, including an explanation of how the device functions, the scientific concepts, and the signific… | 1996 |
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 2 ancestors has a recall.
- 4 other devices also cite its predicate K946094.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Sateliite is intended to acquire EEG data from patients that are stationary or ambulatory, regardless of whether they are inside or outside a medical-care facility.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971331 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971331: Satellite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971331
Report an extraction error
Are you the manufacturer?
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