510(k) · Cleared

Cleared

Sandman SD20 Amplifier

K040113510(k) SpecialCleared Feb 18, 200429-day reviewClass II21 CFR 882.1835

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

Eb Neuro S.P.A. · GWL Amplifier, Physiological Signal

Cleared on Feb 18, 2004 as substantially equivalent to K003154 (Eb Neuro S.P.A., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it.

Decided: Feb 18, 2004
Review: 29 days
Class: Class II
Product code: GWL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003154 (2001). 16 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK003154 Mizar, Basis BE, Sandman DigitalEb Neuro S.P.A. · 2001
This deviceK040113 Sandman SD20 AmplifierEb Neuro S.P.A. · 2004
Descendant · cites it directly · 13 of its ownK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
Descendant · cites it directly · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
Descendant · 2 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
Descendant · 2 generations on · 1 of its ownK170441 ElectroTekMobilemedtek · 2017 · Recalled
Descendant · 2 generations on · 1 of its ownK162681 Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 3 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 16 · See all

K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · cites it directly13descendants
K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · cites it directly7descendants
K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 2 generations on3descendants
K170441ElectroTekMobilemedtek · 2017 · 2 generations on1descendant
K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003154	Mizar, Basis BE, Sandman Digital	Eb Neuro S.P.A.	2001	—
0 (this device)	K040113	Sandman SD20 Amplifier	Eb Neuro S.P.A.	2004	—
+1	K090957	Blackrock Neuroport Biopotential Signal Processing System	I2s Micro Implantable Systems, LLC	2009	2
+1	K103140	Nicolet Wireless Eeg	Carefusion 209, Inc.	2011	1
+2	K122196	Cervello Bio-Potential Signal Acquistion System Product Family	Blackrock Neuromed, LLC	2013	—
+2	K170441	ElectroTek	Mobilemedtek	2017	2
+2	K162681	Enobio Wireless EEG	Neuroelectrics Barcelona S.L.U.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0
2011	1	0
2013	1	0
2015	2	0
2017	3	0
2018	2	0
2021	1	0
2022	2	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K040113, 2001–2026Source: 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 GWL? 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 GWL device

#1 K232210 X-trodes System Mscore 10.4 · 13 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? (1)

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
*	K003154	Mizar, Basis BE, Sandman Digital Summary page 1 …sification Number: 84GWL 807.92(a)(3) Predicate Device(s) EB Neuro, Sp.A. Mizar Amplifier K003 154 Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table. === Page…	Eb Neuro S.P.A.	2001	—

Also cleared against K003154: 4 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K090957	Blackrock Neuroport Biopotential Signal Processing System	I2s Micro Implantable Systems, LLC	2009	13
K103140	Nicolet Wireless Eeg	Carefusion 209, Inc.	2011	7
K223676	SomniCheck	Brainmatterz, LLC	2023	0
K050919	Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…	Analogic Corp.	2005	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?

Its one ancestor has no recall.
Of its descendants, K090957 (I2s Micro Implantable Systems, LLC, 2009) has gone furthest, with 13 descendants of its own.
4 other devices also cite its predicate K003154.

How does its category compare?

All GWL devices

GWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWL

1in 2025

2007high 4 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWL

133in 2024

2007high 133 (2024)2026

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

Recalls per year · GWL

1in 2013

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GWL

1in 2018

2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code GWL, 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	—	0	0
2008	0	—	0	2
2009	2	—	0	0
2010	1	—	1	0
2011	1	—	0	0
2012	2	—	0	0
2013	0	—	1	0
2014	1	—	0	0
2015	1	—	0	0
2016	0	—	0	0
2017	2	—	0	0
2018	1	—	0	1
2019	0	—	0	0
2020	1	—	0	0
2021	2	—	0	0
2022	1	—	0	0
2023	2	—	0	0
2024	4	133	0	0
2025	1	—	0	0
2026	0	—	0	—

What is it indicated for?

The SD20 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040113 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040113: Sandman SD20 Amplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040113

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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