510(k) · Cleared
ClearedPolysmith Sleep System
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 Feb 18, 2015 as substantially equivalent to K062943 (Neurotronics, Inc., 2007) and 1 other predicate after a 145-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- Feb 18, 2015
- Review
- 145 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K915494 (1993). 14 ancestors in all, the oldest K862527 (1986). 4 later devices descend from it, 3 citing it directly.
- 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 deviceK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK173868 Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK251480 PV01 PVDF Effort SensorNeurotronics, LLC · 2025
- Descendant · cites it directly · 0 of its ownK181709 Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK161650 Polysmith Sleep System, Model NTI7593Neurotronics, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018 · cites it directly1descendant
- K251480PV01 PVDF Effort SensorNeurotronics, LLC · 2025 · 2 generations on0descendants
- K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc. · 2018 · cites it directly0descendants
- K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc. · 2017 · cites it directly0descendants
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) | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
| +1 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018 | — |
| +2 | K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | 2025 | — |
| +1 | K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | 2018 | — |
| +1 | K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K062943 | Polysmith Sleep System, Model NTI5498Summary page 5…ame Model Product Codes 510(K) Polysmith Sleep Neurotronics, Inc. NTI5498 OLZ, DQA, OLV K062943 System PSG-1100 Sleep Nihon Kohden Corp. PSG-110… | 2007 |
| * | K120888 | PSG-1100 Sleep Diagnostic SystemSummary page 5…DQA, OLV K062943 System PSG-1100 Sleep Nihon Kohden Corp. PSG-1100 GWQ, OLV K120888 Diagnostic System Pag… | 2012 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K173868 (Neurotronics, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K062943.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. The device is intended for use by healthcare…
Read the full statement (189 words)
The device is intended to measure, amplify, and record physiological signals acquired from a
patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be
analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician
to aid in the diagnosis of Sleep Disorders.
The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or
nursing home; or outside of a medical facility under direct supervision of a medical professional.
The device is intended for use on both adults and children only under the direction of a physician
or qualified sleep technician.
The device or any accessory, does not include alarms, and is not intended to be used as a critical
component of an alarm system.
The device or any accessory, is not to be used alone as an apnea monitor or as a component in an
apnea monitoring system.
The device or any accessory, is not to be used alone as a life support device or as a critical
component of a life support 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/K142774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142774: Polysmith Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142774
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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