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FDA 510(k)

M•care System (MW-20)

K-Number: K253673 · 2026-09-03

ApplicantMarani Health, Inc.
Decision Date2026-09-03
Product CodeLQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

M•care System (MW-20) is the device name listed in this FDA 510(k) record. The listed applicant is Marani Health, Inc.. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K253673. The device is classified under product code LQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M•care System (MW-20)?

M•care System (MW-20) is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Marani Health, Inc.. The 510(k) number is K253673.

When did M•care System (MW-20) receive FDA 510(k) clearance?

M•care System (MW-20) received FDA 510(k) clearance on 2026-09-03, under 510(k) number K253673.

Who is the listed applicant for M•care System (MW-20)?

The FDA 510(k) record lists Marani Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M•care System (MW-20)?

The FDA product code for M•care System (MW-20) is LQK.

Related Devices (Code: LQK)

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.

K221046Invu by NuvoNuvo- Group , Ltd.K210025INVU by NuvoNuvo- Group , Ltd.K191401PregSenseNuvo- Group , 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.

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