FDA 510(k)

BraiN20® (BraiN20)

K-Number: K253301 · 2026-06-27

Decision Date2026-06-27

Product CodeGWF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BraiN20® (BraiN20) is the device name listed in this FDA 510(k) record. The listed applicant is Time IS Brain, S.L.. It received FDA 510(k) clearance on 2026-06-27 under 510(k) number K253301. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BraiN20® (BraiN20)?

BraiN20® (BraiN20) is a medical device that received FDA 510(k) clearance on 2026-06-27. The listed applicant is Time IS Brain, S.L.. The 510(k) number is K253301.

When did BraiN20® (BraiN20) receive FDA 510(k) clearance?

BraiN20® (BraiN20) received FDA 510(k) clearance on 2026-06-27, under 510(k) number K253301.

Who is the listed applicant for BraiN20® (BraiN20)?

The FDA 510(k) record lists Time IS Brain, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BraiN20® (BraiN20)?

The FDA product code for BraiN20® (BraiN20) is GWF.

Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology Incorporated K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated K242345Delphi StimulatorQuantalx Neuroscience K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.