510(k) · Cleared

Cleared

Compumedics Grael System, Models: Grael, Grael Ecg

K093223510(k) TraditionalCleared Jan 15, 201094-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

Compumedics Limited · GWQ Full-Montage Standard Electroencephalograph

Cleared on Jan 15, 2010 as substantially equivalent to K003175 (Compumedics Limited, 2000) and 6 other predicates after a 94-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.

Decided: Jan 15, 2010
Review: 94 days
Class: Class II
Product code: GWQ
Recalls: None
Predicates: 7

Its longest line of descent runs back 3 generations to K000068 (2000). 14 ancestors in all, the oldest K873535 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
2 generations backK021176 Compumedics Somte SystemCompumedics Limited · 2003
1 generation backK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
This deviceK093223 Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010
Descendant · cites it directly · 0 of its ownK230073 OktiCompumedics Limited · 2023

Most influential descendants

Showing 1 of 1 · See all

K230073OktiCompumedics Limited · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000068	Compumedics E-Series Eeg System	Compumedics Neuro Science Pty, Ltd.	2000	1
−2	K021176	Compumedics Somte System	Compumedics Limited	2003	—
−1	K040194	Compumedics Summit IP	Compumedics USA, Ltd.	2004	—
0 (this device)	K093223	Compumedics Grael System, Models: Grael, Grael Ecg	Compumedics Limited	2010	—
+1	K230073	Okti	Compumedics Limited	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1992	1	0
1997	1	0
2000	4	0
2002	1	0
2003	1	0
2008	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K093223, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K003175	Compumedics Siesta System Summary page 1 …stantially equivalent to: Device name: Compumnedics Siesta System Supplier: Compumnedics Limited 510(k) number: K003175 Other predicate devices have been used for comparison where features or technology in the Grael are not present inthe…	Compumedics Limited	2000	—
*	K040194	Compumedics Summit IP Summary page 1 …technology in the Grael are not present inthe Compumnedics Siesta System. Other predicate devices compared are: Compumnedics Summit IP,51 0(k) number K040194 Compumnedics Somt6 PSG, 51 0(k) number K072201 *Compumedics E-Series System, 510(k) No.: K000068…	Compumedics USA, Ltd.	2004	—
*	K072201	Compumedics Somte PSG Recording System Summary page 1 …Siesta System. Other predicate devices compared are: Compumnedics Summit IP,51 0(k) number K040194 Compumnedics Somt6 PSG, 51 0(k) number K072201 *Compumedics E-Series System, 510(k) No.: K000068 • Compumedics P-Series System, 510(k) No.: K955841…	Compumedics Limited	2008	—
*	K000068	Compumedics E-Series Eeg System Summary page 1 …Compumnedics Summit IP,51 0(k) number K040194 Compumnedics Somt6 PSG, 51 0(k) number K072201 Compumedics E-Series System, 510(k) No.: K000068 • Compumedics P-Series System, 510(k) No.: K955841 * Neuroscan Labs Scan LT4O, 51 0(k) No.: KO0l 564…	Compumedics Neuro Science Pty, Ltd.	2000	1
*	K955841	Sleep System for Clinics & Research Summary page 1 …Compumnedics Somt6 PSG, 51 0(k) number K072201 Compumedics E-Series System, 510(k) No.: K000068 • Compumedics P-Series System, 510(k) No.: K955841 Neuroscan Labs Scan LT4O, 51 0(k) No.: KO0l 564 * Compumnedics Neuvo System, 51 0(k) No.: K081 151 Comp…	Compumedics Ptd, Ltd.	1997	—
*	K001564	Scan LT40 (40 Channels) Summary page 3 …on EEG, (4.0) software is identical to that inthe Neuvo System (K081 151) * Photic Stimulator - Identical to that'lincluded with the Scan LT40 (K001564) Compumedics Greas Systfern 510(k) Submission is 4 ~DEPARTMENT OF…	Neuro Scan Labs	2000	—
*	K081151	Compumedics Neuvo Summary page 1 …• Compumedics P-Series System, 510(k) No.: K955841 * Neuroscan Labs Scan LT4O, 51 0(k) No.: KO0l 564 * Compumnedics Neuvo System, 51 0(k) No.: K081 151 Compumedica Onae! System 510(k) Submission 13 Description of the S…	Compumedics USA, Ltd.	2008	—

Also cleared against K003175: 5 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K230073	Okti	Compumedics Limited	2023	0

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 10 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
1 of the 14 ancestors has a recall of any class.
Of its descendants, K230073 (Compumedics Limited, 2023) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K003175.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · GWQ

1in 2024

2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2007high 276 (2015) · low 50 (2016)2026

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

Recalls per year · GWQ

1in 2020

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

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

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 GRAEL SYSTEM is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movemeht, breathing and body movements to assist in the diagnosis of various sleep disorders or neurological disorders. The Grael is designed for use in a hospital or other clinical environment. The Grael is only to be used under the direction of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093223 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093223: Compumedics Grael System, Models: Grael, Grael Ecg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093223

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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