510(k) · Cleared
ClearedMaxxi Position Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovirtual USA, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Apr 24, 2020 as substantially equivalent to K131335 (Neurovirtual USA, Inc., 2015) and 2 other predicates after a 324-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Apr 24, 2020
- Review
- 324 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923033 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923033 | The Tracker | Epm Information Systems, Inc. | 1993 | — |
| −1 | K981969 | Ultima Body Position Sensor | Braebon Medical Corp. | 1998 | — |
| 0 (this device) | K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2004 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K131335 | Bwmini Eeg, Bwminihst, Bwmini PSGSummary page 4…bstantial Equivalence: The Maxxi Position Sensor is equivalent with the following products: 510(k) Number Model Company K131335 BWMINI NEUROVIRTUAL USA INC. K981969 ULTIMA BODY POSITION SENSOR… | 2015 |
| * | K981969 | Ultima Body Position SensorSummary page 4…roducts: 510(k) Number Model Company K131335 BWMINI NEUROVIRTUAL USA INC. K981969 ULTIMA BODY POSITION SENSOR BRAEBON MEDICAL CORP.… | 1998 |
| * | K923033 | The TrackerSummary page 5…Position Sensor 510(k) K131335 Number K191492 K923033 NA Classification GWQ, OLV GWQ, OLV LEL The pre… | 1993 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 21.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Maxxi Position Sensor is intended for use with the BWMini polysomnograph system, to acquire the body position of adult patients during sleep studies. The Sensor produces signals for five positions: standing/sitting, supine, prone, left and right. It is intended for use in research, home sleep studies, ambulatory, and clinical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191492: Maxxi Position Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191492
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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