510(k) Report

510(k) · Cleared

Cleared

Cadwell Easy Ambulatory Eeg

K946094510(k) TraditionalCleared Sep 12, 1995272-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 Sep 12, 1995 after a 272-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 78 later devices descend from it.

Decided
Sep 12, 1995
Review
272 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

78 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2015: 2 descendants cleared2005: 1 descendant cleared1997: 1 descendant cleared2020: 5 descendants cleared2023: 7 descendants cleared2017: 3 descendants cleared2022: 8 descendants cleared1999: 2 descendants cleared2009: 3 descendants cleared2016: 4 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2011: 2 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2024: 4 descendants cleared2021: 3 descendants cleared2025: 9 descendants cleared2026: 9 descendants cleared2012: 1 descendant cleared2018: 3 descendants cleared2013: 1 descendant cleared2019: 2 descendants cleared1995200020052010201520202025
  1. This deviceK946094 Cadwell Easy Ambulatory EegCadwell Laboratories, Inc. · 1995
  2. Descendant · cites it directly · 61 of its ownK971813 EMBLAFerguson Medical · 1998
  3. Descendant · 2 generations on · 25 of its ownK080427 Watch-Pat Model 100S-2Itamar Medical · 2008
  4. Descendant · 3 generations on · 24 of its ownK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
  5. Descendant · 2 generations on · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
  6. Descendant · 2 generations on · 23 of its ownK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 22005: 12007: 12008: 22009: 32010: 22011: 22012: 12013: 12014: 22015: 22016: 42017: 32018: 32019: 22020: 52021: 32022: 82023: 72024: 42025: 92026: 9
1997high 9 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 78 · See all
  • K971813EMBLAFerguson Medical · 1998 · cites it directly61descendants
  • K080427Watch-Pat Model 100S-2Itamar Medical · 2008 · 2 generations on25descendants
  • K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008 · 3 generations on24descendants
  • K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · 2 generations on23descendants
  • K070375Earlysense ES-16 SystemEarlysense, Ltd. · 2007 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K946094Cadwell Easy Ambulatory EegCadwell Laboratories, Inc.1995—
+1K971813EMBLAFerguson Medical1998—
+2K080427Watch-Pat Model 100S-2Itamar Medical2008—
+3K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical2008—
+2K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.2011—
+2K070375Earlysense ES-16 SystemEarlysense, Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200510
200710
200820
200930
201020
201120
201210
201310
201420
201520
201640
201730
201830
201920
202050
202130
202280
202370
202440
202590
202690
FIG. 1 — Lineage of K946094, 1995–2026Source: 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K971813EMBLAFerguson Medical199861
K143233Mitsar-EEGMitsar Co., Ltd.201511
K131335Bwmini Eeg, Bwminihst, Bwmini PSGNeurovirtual USA, Inc.20151
K050143Omnipro SystemMays and Associates, Inc.20050
K971331SatelliteNicolet Biomedical, Inc.19970

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, K971813 (Ferguson Medical, 1998) has gone furthest, with 61 descendants 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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https://510kreport.com/device/K946094 · printed Nov 5, 2026

Cite this page

510(k) Report. “K946094: Cadwell Easy Ambulatory Eeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946094

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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