510(k) · Cleared
Recalled · Class II · 2020PSG-1100 Sleep Diagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corp. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Nov 9, 2012 as substantially equivalent to K022121 (Nihon Kohden America, Inc., 2002) and 3 other predicates after a 231-day review. Its family tree reaches back 5 generations to 1993. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K915494 (1993). 13 ancestors in all, the oldest K862527 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK915494 Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Nellcor, Inc. · 1993
- 4 generations backK964305 Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with AccessoriesNihon Kohden America, Inc. · 1997
- 3 generations backK990063 Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesNihon Kohden America, Inc. · 1999
- 2 generations backK040875 Cap-One, Model TG-920PNihon Kohden America, Inc. · 2004
- 1 generation backK050833 Electrode Junction Box, Model JE-921ANihon Kohden America, Inc. · 2005
- This deviceK120888 PSG-1100 Sleep Diagnostic SystemNihon Kohden Corp. · 2012
- 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
- Descendant · 2 generations on · 0 of its ownK161650 Polysmith Sleep System, Model NTI7593Neurotronics, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | 1993 | — |
| −4 | K964305 | Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories | Nihon Kohden America, Inc. | 1997 | — |
| −3 | K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −2 | K040875 | Cap-One, Model TG-920P | Nihon Kohden America, Inc. | 2004 | — |
| −1 | K050833 | Electrode Junction Box, Model JE-921A | Nihon Kohden America, Inc. | 2005 | — |
| 0 (this device) | K120888 | PSG-1100 Sleep Diagnostic System | Nihon Kohden Corp. | 2012 | — |
| +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 | — |
| +2 | 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 |
|---|---|---|
| 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 GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 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 |
|---|---|---|---|
| * | K022121 | PSG Input Box, Model JE-912AKSummary page 1…Electroencephalograph Predicate Device Nihon Kohden JE-912A PSG Input Box K022121 Additional predicates Nihon Kohden EEG-1200A Series Neurofax… | 2002 |
| * | K080546 | Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200ASummary page 6…c System) was shown to be equivalent in safetyand effectiveness to the predicate devices, JE-912A PSG Input Box k022121 and the JIE-921A Junction Box k050833/k080546, No new questions of safety or effectiveness are raised.… | 2008 |
| * | K050833 | Electrode Junction Box, Model JE-921ASummary page 3…Page, 2 of 6 K050833/080546 K022121 Number of 42 32 34 Channels(*)… | 2005 |
| * | K062943 | Polysmith Sleep System, Model NTI5498Summary page 1…K(050833 Neurotronics Polysmith K(062943 Page 1 of 6 1.0 De… | 2007 |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2020 | Class II | Z-0865-2021 | Device Design | Medical device non-conformance to electrical safety standard (IEC 60601-1). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K142774 (Neurotronics, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K022121.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The PSG- 1100 Sleep Diagnostic System is intended to record the physiological data required for BEG and sleep studies (Polysomnography or PSG). These data may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120888 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120888: PSG-1100 Sleep Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120888
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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