510(k) · Cleared
ClearedNeurotronics Polysomnography System 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotronics, Inc. · MNR Ventilatory Effort Recorder
Cleared on Nov 12, 1997 as substantially equivalent to K862527 (Micro Tronics Corp., 1986) after a 184-day review. Its family tree reaches back 1 generation to 1986. 8 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 184 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862527 (1986). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK862527 Sleep Analyzing ComputerMicro Tronics Corp. · 1986
- This deviceK971803 Neurotronics Polysomnography System 101Neurotronics, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK062943 Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK173868 Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK251480 PV01 PVDF Effort SensorNeurotronics, LLC · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K062943Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007 · cites it directly7descendants
- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · 2 generations on6descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · 2 generations on4descendants
- K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018 · 3 generations on1descendant
- K251480PV01 PVDF Effort SensorNeurotronics, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862527 | Sleep Analyzing Computer | Micro Tronics Corp. | 1986 | — |
| 0 (this device) | K971803 | Neurotronics Polysomnography System 101 | Neurotronics, Inc. | 1997 | — |
| +1 | K062943 | Polysmith Sleep System, Model NTI5498 | Neurotronics, Inc. | 2007 | — |
| +2 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +2 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
| +3 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018 | — |
| +4 | K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 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 |
|---|---|---|---|
| * | K862527 | Sleep Analyzing ComputerSummary page 1…same intended use, to the Microtronics SAC system. The same individual (Dr. Jack R. Smith) designed both systems. On October 6, 1986, the FDA notified Microtronics (Re: K8625277) that their sleep-analyzing computer was determined to be substantially equivalent to devices in interstate commerce prior to Ma… | 1986 |
| † | K863124 | Model 8 Eeg Preamplifier | 1986 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062943 | Polysmith Sleep System, Model NTI5498 | 2007 | 7 |
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?
- Its one ancestor has no recall.
- Of its descendants, K062943 (Neurotronics, Inc., 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 13 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.
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/K971803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971803: Neurotronics Polysomnography System 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971803
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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