510(k) · Cleared
ClearedCadwell Flex Eeg/PSG
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 Jan 29, 2014 as substantially equivalent to K093728 (Eb Neuro S.P.A., 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Jan 29, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962603 (1997). 18 ancestors in all, the oldest K930790 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 3 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 2 generations backK061996 Sandman PocketEb Neuro S.P.A. · 2006
- 1 generation backK093728 BE Micro, TreaEb Neuro S.P.A. · 2010
- This deviceK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −3 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −2 | K061996 | Sandman Pocket | Eb Neuro S.P.A. | 2006 | — |
| −1 | K093728 | BE Micro, Trea | Eb Neuro S.P.A. | 2010 | — |
| 0 (this device) | K133355 | Cadwell Flex Eeg/PSG | Cadwell Industries, Inc. | 2014 | — |
| +1 | K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018 | — |
| +2 | K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020 | — |
| +3 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K093728 | BE Micro, Trea Our reading of the summary gave K091728, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “E13 Neuro BE micro Trea”. | 2010 |
| * | K971214 | KilowinSummary page 1…L, OLT, OWE, OWL Classification Panel: Neurological Predicate Devices: E13 Neuro BE micro Trea (K091728) Cadwell Kilowin (K97 1214) Device Description: The Cadwell Flex BEG/PSGO systemo consists Of- (1) acquisition hard… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180269 | Cadwell Apollo System | 2018 | 2 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K180269 (Cadwell Industries, Inc., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Cadwell Flex system is indicated for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133355: Cadwell Flex Eeg/PSG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133355
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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