FDA 510(k)

Clearo

K-Number: K242438 · 2025-05-16

Decision Date2025-05-16

Product CodeNHJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Clearo is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K242438. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clearo?

Clearo is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Breas Medical AB. The 510(k) number is K242438.

When did Clearo receive FDA 510(k) clearance?

Clearo received FDA 510(k) clearance on 2025-05-16, under 510(k) number K242438.

Who is the listed applicant for Clearo?

The FDA 510(k) record lists Breas Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clearo?

The FDA product code for Clearo is NHJ.

Other records listing Breas Medical AB as applicant

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.

K242485EveryWare K233452Vivo 45 LS K240779Vivo 3 K240778Vivo 1, Vivo 2 K193586Vivo 45 LS K160481Vivo 60

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Related Devices (Code: NHJ)

K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K231728BiWaze Clear SystemAbmrc, LLC K213564BiWaze Clear SystemAbmrc, LLC K200988Maximus SystemHill-Rom Services Pte, Ltd.K191912BiWaze CoughAbmrc, LLC K192143Maximus SystemHill-Rom Services Pte, Ltd.

Official Source

View on FDA Database →

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