510(k) Report

510(k) · Cleared

Cleared

Cadwell Easy Writer and Easy Reader

K932407510(k) TraditionalCleared Mar 22, 1994308-day reviewClass II21 CFR 882.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cadwell Laboratories, Inc. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Mar 22, 1994 after a 308-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 22, 1994
Review
308 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK932407 Cadwell Easy Writer and Easy ReaderCadwell Laboratories, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK062533 Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006
  3. Descendant · cites it directly · 0 of its ownK112107 Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006 · cites it directly1descendant
  • K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932407Cadwell Easy Writer and Easy ReaderCadwell Laboratories, Inc.1994—
+1K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc.2006—
+1K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201110
FIG. 1 — Lineage of K932407, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc.20061
K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc.20110

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?

  • Of its descendants, K062533 (Neurovirtual USA, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GWQ devices

GWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWQ

1in 2024

2007: 12008: 22010: 32011: 42012: 42013: 22014: 22015: 32016: 32017: 52018: 82020: 62022: 32023: 62024: 12026 (partial year): 2
2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2010: 73 days median2011: 220 days median2012: 208 days median2015: 276 days median2016: 50 days median2017: 181 days median2018: 150 days median2020: 216 days median2022: 216 days median2023: 137 days median
2007high 276 (2015) · low 50 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWQ

1in 2020

2007: 52008: 22009: 12010: 12015: 22019: 22020: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWQ

13in 2025

2007: 112008: 82009: 72010: 122011: 62012: 92013: 42014: 72015: 132016: 282017: 172018: 152019: 162020: 302021: 202022: 162023: 202024: 172025: 13
2007high 30 (2020) · low 4 (2013)2025

MAUDE reports naming product code GWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—511
20082—28
20090—17
2010373112
2011422006
2012420809
20132—04
20142—07
20153276213
2016350028
20175181017
20188150015
20190—216
20206216130
20210—020
20223216016
20236137020
20241—017
20250—013
20262—1—

More from Cadwell Laboratories, Inc.

46 FDA decisions under this applicant name. See the company

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  • K042350Tes-1 Constant Voltage Electrical StimulatorCadwell Laboratories, Inc. · 2004
  • K040932Easynet Body Position ModuleCadwell Laboratories, Inc. · 2004
  • K040986Cadwell Limb Movement ModuleCadwell Laboratories, Inc. · 2004

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The GWQ category page

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https://510kreport.com/device/K932407 · printed Nov 4, 2026

Cite this page

510(k) Report. “K932407: Cadwell Easy Writer and Easy Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932407

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026