510(k) · Cleared
ClearedLive View Panel (LVP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotronics, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 9, 2013 as substantially equivalent to K080546 (Nihon Kohden America, Inc., 2008) and 3 other predicates after an 85-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Aug 9, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K915494 (1993). 15 ancestors in all, the oldest K862527 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- 5 generations backK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- 4 generations backK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- 3 generations backK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- 2 generations backK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- 1 generation backK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- This deviceK131415 Live View Panel (LVP)Neurotronics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| −5 | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| −4 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −3 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| −2 | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| −1 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| 0 (this device) | K131415 | Live View Panel (LVP) | Neurotronics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 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? (4)
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 |
|---|---|---|---|
| * | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ASummary page 2…jDevice Name Model 510(K) Nihon Kohden America, Inc. Nihon Kohden EEG-1I200A Series EEG-1200A K080546 Neurofax Neurotronics, Inc. Polysmith Sleep System NT15498… | 2008 |
| * | K062943 | Polysmith Sleep System, Model NTI5498Summary page 2…EEG-1200A K080546 Neurofax Neurotronics, Inc. Polysmith Sleep System NT15498 K062943 Nihon Kohden Corp. PSG-l 1100 Sleep Diagnostic System PSG-1I 100 K120888… | 2007 |
| * | K120888 | PSG-1100 Sleep Diagnostic SystemSummary page 2…Polysmith Sleep System NT15498 K062943 Nihon Kohden Corp. PSG-l 1100 Sleep Diagnostic System PSG-1I 100 K120888 Nihon Kohden EEG-1I200A with JE- Nihon Kohden America, Inc. 120A Multi Channel Ele… | 2012 |
| * | K113117 | Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction BoxSummary page 2…0888 Nihon Kohden EEG-1I200A with JE- Nihon Kohden America, Inc. 120A Multi Channel Electrode JE-120A KI113117 Junction Box DESCRIPTION The Live View Panel (LVP) consists of several soft… | 2012 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 4 other devices also cite its predicate K080546.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Live View Panel is an accessory to EEG and PSG systems, intended to transmit EEG or PSG data to a remote location where the data can be viewed by a clinician to aid in diagnosis of epilepsies, sleep disorders, and other related disorders The Live View Panel is intended for use by medical personnel within a medical facility, clinic or nursing home, or outside a medical facility under the supervision of a medical professional. The Live View Panel is…
Read the full statement (124 words)
The Live View Panel is an accessory to EEG and PSG systems, intended to transmit EEG or PSG data to a remote location where the data can be viewed by a clinician to aid in diagnosis of epilepsies, sleep disorders, and other related disorders
The Live View Panel is intended for use by medical personnel within a medical facility, clinic or nursing home, or outside a medical facility under the supervision of a medical professional. The Live View Panel is available for use on all patient populations, including adults and children as determined by the medical professional.
This device is not to be used to monitor life threatening situations.
This device is not to be used to control life supporting or life sustaining devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131415: Live View Panel (LVP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131415
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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