510(k) · Cleared
ClearedCadwell Zenith System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Industries, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Sep 1, 2018 as substantially equivalent to K143440 (Natus Medical Incorporated, 2015) and 2 other predicates after an 89-day review. Its family tree reaches back 17 generations to 1994.
- Decided
- Sep 1, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K941811 (1994). 212 ancestors in all, the oldest K802637 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 13 generations between
- 3 generations backK090599 MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- 2 generations backK152563 Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd. · 2016
- 1 generation backK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- This deviceK181466 Cadwell Zenith SystemCadwell Industries, Inc. · 2018
Show all 17 generations
- Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 16 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 15 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 14 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 13 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 12 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 11 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 10 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 9 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 8 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 7 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 6 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 5 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 4 generations backK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 3 generations backK090599 MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- 2 generations backK152563 Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd. · 2016
- 1 generation backK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- This deviceK181466 Cadwell Zenith SystemCadwell Industries, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −16 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −15 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −14 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −13 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −12 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −11 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −10 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −9 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −8 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −7 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −6 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −5 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −4 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −3 | K090599 | MD300K1 Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| −2 | K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | 2016 | — |
| −1 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| 0 (this device) | K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 8 | 0 |
| 1991 | 3 | 0 |
| 1992 | 8 | 0 |
| 1993 | 9 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 9 | 0 |
| 1997 | 12 | 0 |
| 1998 | 12 | 0 |
| 1999 | 16 | 0 |
| 2000 | 17 | 0 |
| 2001 | 6 | 0 |
| 2002 | 15 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K143440 | Natus QuantumSummary page 4…Predicate Predicate Equivalent Devices: 510(k) Number Manufacturer / Model Cadwell Zenith System K143440, Natus Medical K180181 Incorporated DBA Excel-… | 2015 |
| * | K180181 | Natus QuantumSummary page 4…510(k) Number Manufacturer / Model Cadwell Zenith System K143440, Natus Medical K180181 Incorporated DBA Excel- Tech Ltd. (XLTEK) /… | 2018 |
| * | K162199 | Cascade IOMAX Intraoperative MonitorSummary page 4…Tech Ltd. (XLTEK) / Natus Quantum (primary) K162199 Cadwell Industries Inc. / Cascade IOMAX… | 2017 |
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 24 years and passes through 9 companies; a new generation was cleared every 6 months on median.
- 30 of the 212 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143440.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Zenith is an electroneurodiagnostic device that accepts, measures, displays, records, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used…
Read the full statement (110 words)
Zenith is an electroneurodiagnostic device that accepts, measures, displays, records, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neurodiagnostic evaluations, including EEG and direct cortical stimulation. Zenith is used with Cadwell acquisition software.
Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing on patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181466: Cadwell Zenith System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181466
Report an extraction error
Are you the manufacturer?
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