510(k) · Cleared
ClearedElectrode Junction Box, Model JE-921A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Apr 29, 2005 as substantially equivalent to K022121 (Nihon Kohden America, Inc., 2002) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1993. 7 later devices descend from it.
- Decided
- Apr 29, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915494 (1993). 6 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- 3 generations backK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- 2 generations backK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- 1 generation backK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- This deviceK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- Descendant · cites it directly · 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
- Descendant · 3 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 · 2 generations on4descendants
- K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc. · 2018 · 3 generations on1descendant
- K251480PV01 PVDF Effort SensorNeurotronics, LLC · 2025 · 4 generations on0descendants
- K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| −3 | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| −2 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −1 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| 0 (this device) | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| +1 | 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 | — |
| +3 | 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 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 |
|---|---|---|---|
| * | K022121 | PSG Input Box, Model JE-912AKSummary page 1…el under 21 CFR Part 868.1400 "Analyzer, gas, carbon dioxide, gaseous-phase" as per part 73 CCK. Legally Marketed Predicate: Nihon Kohden JE-912AK, cleared per 510(k): K022121, is in commercial distribution certification dated 7/29/2002. The CO 2 module, in commercial distribution, has been previously cl… | 2002 |
| * | K040875 | Cap-One, Model TG-920PSummary page 1…k): K022121, is in commercial distribution certification dated 7/29/2002. The CO 2 module, in commercial distribution, has been previously cleared under 510K submission, K040875, dated 10/15/2004. There are no significant changes in function, biocompatibility, performance or manufacturability compared to… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120888 | PSG-1100 Sleep Diagnostic System | 2012 | 6 |
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 12 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 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 OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool. As with the predicate, the information transferred to EEG will be…
Read the full statement (130 words)
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool. As with the predicate, the information transferred to EEG will be stored, interpreted and printed with commercially software programs available with Nihon Kohden marketed products.
The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050833: Electrode Junction Box, Model JE-921A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050833
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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