DeviceClearance

Mcare System (MW-20)— 510(k) K253673

Substantially Equivalent

Marani Health, Inc.

FDA 510(k) clearance K253673 for Mcare System (MW-20), Substantially Equivalent on 2026-09-03. Applicant: Marani Health, Inc.. Device class: 2.

Summary

Marani Health's Mcare System (MW-20) is filed under LQK, home uterine activity monitors. The record doesn't describe it beyond the model number and code name.

Class II, 21 CFR 884.2730. Obstetrics/Gynecology is both the classification panel and the review panel. It was a Traditional 510(k).

Marani Health filed from Oakdale, Minnesota. The decision came 286 calendar days after receipt (November 21, 2025 to September 3, 2026).

Clearance details

Applicant
Marani Health, Inc.
Product code
Product code LQK
Device class
Class 2
Regulation
21 CFR 884.2730
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oakdale, MN, US
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