510(k) · Cleared
ClearedNomadAir PMU810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotronics, Inc. · GWL Amplifier, Physiological Signal
Cleared on Jul 15, 2022 as substantially equivalent to K092699 (Neurotronics, Inc., 2010) after a 133-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- Jul 15, 2022
- Review
- 133 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092699 (2010). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K223676SomniCheckBrainmatterz, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092699 | Nomad Sleep System Recorder, Model PMU800 | Neurotronics, Inc. | 2010 | — |
| 0 (this device) | K220631 | NomadAir PMU810 | Neurotronics, Inc. | 2022 | — |
| +1 | K223676 | SomniCheck | Brainmatterz, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 GWL? 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 GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K092699 | Nomad Sleep System Recorder, Model PMU800Summary page 5…eurotronics®, Inc. regards the NomadAir PMU810 to be substantially equivalent to other legally marketed devices including the predicate the NOMAD, Polysmith Sleep System K092699 and the Reference Device ApneaTrak K192624. 4 Subject Device Description The NomadAir PMU810 is a portable device that records… | 2010 |
| † | K192624 | ApneaTrak | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223676 | SomniCheck | 2023 | 0 |
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?
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NomadAir PMUS810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMUS810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMUS810 is intended for use on…
Read the full statement (132 words)
The NomadAir PMUS810 is intended to record physiological signals acquired from a patient for archival in a sleep study.
Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep
clinician to aid in the diagnosis of sleep-disordered breathing (SDB).
The NomadAir PMUS810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home.
The NomadAir PMUS810 is intended for use on adults only under the direction of a physician or qualified sleep technician.
The NomadAir PMUS810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a
critical component of,
* an alarm or alarm system;
* an apnea monitor or apnea monitoring system; or
* a life monitor or life monitoring system.
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/K220631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220631: NomadAir PMU810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220631
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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