510(k) Report

510(k) · Cleared

Cleared

Bio-Logic Ceegraph Netlink

K002570510(k) SpecialCleared Sep 14, 200027-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

Bio-Logic Systems Corp. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Sep 14, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Sep 14, 2000
Review
27 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK002570 Bio-Logic Ceegraph NetlinkBio-Logic Systems Corp. · 2000
  2. Descendant · cites it directly · 5 of its ownK052066 Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp. · 2005 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK093728 BE Micro, TreaEb Neuro S.P.A. · 2010
  4. Descendant · 3 generations on · 3 of its ownK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
  5. Descendant · 4 generations on · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
  6. Descendant · 5 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12010: 12014: 12018: 12020: 12023: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K052066Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp. · 2005 · cites it directly5descendants
  • K093728BE Micro, TreaEb Neuro S.P.A. · 2010 · 2 generations on4descendants
  • K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014 · 3 generations on3descendants
  • K180269Cadwell Apollo SystemCadwell Industries, Inc. · 2018 · 4 generations on2descendants
  • K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002570Bio-Logic Ceegraph NetlinkBio-Logic Systems Corp.2000—
+1K052066Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp.20052
+2K093728BE Micro, TreaEb Neuro S.P.A.2010—
+3K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc.2014—
+4K180269Cadwell Apollo SystemCadwell Industries, Inc.2018—
+5K201819Cadwell Apollo SystemCadwell Industries, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201010
201410
201810
202010
202310
FIG. 1 — Lineage of K002570, 2000–2023Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052066Ceegraph/Sleepscan Netlink TravelerBio-Logic Systems Corp.20055

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, K052066 (Bio-Logic Systems Corp., 2005) has gone furthest, with 5 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—
Cite this page

510(k) Report. “K002570: Bio-Logic Ceegraph Netlink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002570

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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