510(k) · Cleared
ClearedPolysmith Sleep System, Model NTI5498
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotronics, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on May 9, 2007 as substantially equivalent to K022121 (Nihon Kohden America, Inc., 2002) and 1 other predicate after a 223-day review. Its family tree reaches back 2 generations to 1986. 7 later devices descend from it.
- Decided
- May 9, 2007
- Review
- 223 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K862527 (1986). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK862527 Sleep Analyzing ComputerMicro Tronics Corp. · 1986
- 1 generation backK971803 Neurotronics Polysomnography System 101Neurotronics, Inc. · 1997
- This deviceK062943 Polysmith Sleep System, Model NTI5498Neurotronics, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK142774 Polysmith Sleep SystemNeurotronics, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK173868 Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK251480 PV01 PVDF Effort SensorNeurotronics, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK181709 Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120888PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012 · cites it directly6descendants
- K142774Polysmith Sleep SystemNeurotronics, Inc. · 2015 · cites it directly4descendants
- K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018 · 2 generations on1descendant
- K251480PV01 PVDF Effort SensorNeurotronics, LLC · 2025 · 3 generations on0descendants
- K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862527 | Sleep Analyzing Computer | Micro Tronics Corp. | 1986 | — |
| −1 | K971803 | Neurotronics Polysomnography System 101 | Neurotronics, Inc. | 1997 | — |
| 0 (this device) | K062943 | Polysmith Sleep System, Model NTI5498 | Neurotronics, Inc. | 2007 | — |
| +1 | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | 1 |
| +1 | K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015 | — |
| +2 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018 | — |
| +3 | K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | 2025 | — |
| +2 | K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 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 |
|---|---|---|---|
| * | K022121 | PSG Input Box, Model JE-912AKSummary page 1….Z, oLV, "DRA Establishment Registration Number of Manufacturer 1063925 Legally Marketed Predicate Nihon Kohden PSG Input Box, Model JE-912AK, cleared under 510(k), K022121 Polysmith cleared under 510(k), K971803 27 Traditional 510(K) Notification Polysmith Sleep System Summary of Te… | 2002 |
| * | K971803 | Neurotronics Polysomnography System 101Summary page 1…on Number of Manufacturer 1063925 Legally Marketed Predicate Nihon Kohden PSG Input Box, Model JE-912AK, cleared under 510(k), K022121 Polysmith cleared under 510(k), K971803 27 Traditional 510(K) Notification Polysmith Sleep System Summary of Technological Characteristics of Device Co… | 1997 |
What descends from it? (7)
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 21 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120888 (Nihon Kohden Corp., 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K022121.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 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. This device, or any accessory, is not to be used…
Read the full statement (135 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.
This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
This 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.
This device is intended for use on both adults and children 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/K062943 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062943: Polysmith Sleep System, Model NTI5498.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062943
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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