Cleared Traditional

K253673 - M•care System (MW-20)

K253673 is an FDA 510(k) clearance for M•care System (MW-20), manufactured by Marani Health, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LQK cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K253673 · Marani Health, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
286d
Days
Class 2
Risk

K253673 is an FDA 510(k) clearance for the M•care System (MW-20). Classified as Home Uterine Activity Monitor (product code LQK), Class II - Special Controls.

Submitted by Marani Health, Inc. (Oakdale, US). The FDA issued a Cleared decision on September 3, 2026 after a review of 286 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marani Health, Inc. devices

FDA 510(k) Submission Details - K253673

510(k) Number K253673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date September 03, 2026
Days to Decision 286 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 161d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

LQK Device Classification - Class 2, Special Controls

Product Code LQK Home Uterine Activity Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05294211 Completed Interventional Industry-sponsored

Safety and Performance of a Fetal Monitoring System

Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study

120
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Pregnancy
Study design Single group
Eligibility Female only · 18 Years+
Sponsor Marani Health (industry)
Started 2022-08-31 → Primary completion 2023-01-24
Primary outcome
Fetal Heart Rate (FHR)
Secondary outcome
Uterine Contractions (UC)
View full study on ClinicalTrials.gov

Regulatory Peers - LQK Home Uterine Activity Monitor

Devices cleared under the same product code (LQK) and FDA review panel - the closest regulatory comparables to K253673.
Invu by Nuvo
K221046 · Nuvo- Group , Ltd. · May 2022
INVU by Nuvo
K210025 · Nuvo- Group , Ltd. · May 2021
PregSense
K191401 · Nuvo- Group , Ltd. · Mar 2020
Sense4Baby System Model B+ (MSA)
K143114 · Airstrip Technologies, Inc. · Mar 2015
MODIFICATION TO FETAL ASSIST
K020390 · Huntleigh Diagnostics , Ltd. · Apr 2002