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Discovery 24

by BrainMaster Technologies, Inc.

510(k) K150498Ref 390-040, 390-030Model Atlantis 2x2, Atlantis 4x4, Discovery 20

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150498↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0852391007003UN Basic UDI-DI Date22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00852391007027 UDI-DI Date15 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK150498 Date26 Jan 2016ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0852391007003UN registered 22 May 2026 Active
  • FDA 510(k) K150498 decided 26 Jan 2016 Active
  • FDA GUDID UDI-DI 00852391007027 listed 15 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150498
  2. Listed FDA GUDID 00852391007027
  3. Registered EUDAMED 0852391007003UN

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
BrainMaster Technologies EUDAMED
Atlantis 2x2 EUDAMED
Atlantis 4x4 EUDAMED
Atlantis GUDID
Generic name
Electroencephalograph
Device name
Atlantis II
Atlantis I
Discovery 20
Model / Ref / Catalog
Atlantis 4x4, Atlantis 2x2, 390-040, 390-030, Discovery 20, Atlantis II 2x2
Primary DI / UDI-DI
00852391007027, 00852391007003
Basic UDI-DI
0852391007003UN, 0852391007027V4, 0852391007EEG2X
Direct marketing DI
00852391007003
00852391007027
510(k) Number
FDA product code
GWQ 510(k)
HCC GUDID
EMDN code
Z12100302 Electroencephalographs
GMDN term
Electroencephalograph
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 882.1400 510(k)
882.5050 GUDID
System or procedure pack
System which is a device in itself
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA product codeEUDAMED
—
510(k)
GWQ
GUDID
HCC
Device classEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II
Regulation numberEUDAMED
—
510(k)
882.1400
GUDID
882.5050

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Discovery 24 is a Full-Montage Standard Electroencephalograph (EEG), a Class II medical device designed for recording electrical activity in the brain. It provides high-resolution, 24-channel EEG data capture, enabling detailed monitoring of neural signals for diagnostic and research purposes in neurology.

This device is supplied as a reusable, portable system powered via USB, intended for clinical, laboratory, or remote/home use with compatible laptop computers. It is regulated under FDA 510(k) clearance and EU MDR, with a device classification of Class II. The system incorporates low-noise DC-sensitive amplifiers and 24-bit analog-to-digital converters for optimal signal clarity.

From the manufacturer

This innovative system is built on the latest advancements in the BrainMaster series, offering an impressive 24 channels of EEG biofeedback. Equipped with cutting-edge low-noise DC-sensitive amplifiers and 24-bit analog-to-digital converters, the Discovery 24 guarantees exceptional clarity and high-resolution data capture.

Source: brainmaster.com

Discovery Series The Discovery series introduces the next generation of EEG biofeedback! in high-quality, low-cost system with up to 24 channels, answering the advanced needs of the clinical and research communities. A lightweight, portable device, it is ideal for remote or home training with laptop computers, as well as clinical or laboratory use. Entirely powered by USB interface.

Source: brainmaster.com

Devices cleared under K150498

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K150498
UDI-DISize and differences
Discovery Discovery 20
BrainMaster Technologies, Inc.
390-070 / Discovery 2000852391007041 —On the market
Discovery Discovery 24
BrainMaster Technologies, Inc.
390-060 / Discovery 2400852391007010 —On the market

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Properties

  • Measuring function
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)