510(k) · Cleared

Cleared

M•care System (MW-20)

K253673510(k) TraditionalCleared Sep 3, 2026286-day reviewClass II21 CFR 884.2730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Marani Health, Inc. · LQK Home Uterine Activity Monitor

Cleared on Sep 3, 2026 as substantially equivalent to K143114 (Airstrip Technologies, Inc., 2015) after a 286-day review. Its family tree reaches back 3 generations to 2001.

Decided: Sep 3, 2026
Review: 286 days
Class: Class II
Product code: LQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K002548 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK002548 Fetal AssistHuntleigh Diagnostics, Ltd. · 2001
2 generations backK020390 Modification to Fetal AssistHuntleigh Diagnostics, Ltd. · 2002
1 generation backK143114 Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 2015 · Recalled
This deviceK253673 M•care System (MW-20)Marani Health, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002548	Fetal Assist	Huntleigh Diagnostics, Ltd.	2001	—
−2	K020390	Modification to Fetal Assist	Huntleigh Diagnostics, Ltd.	2002	—
−1	K143114	Sense4Baby System Model B+ (MSA)	Airstrip Technologies, Inc.	2015	1
0 (this device)	K253673	M•care System (MW-20)	Marani Health, Inc.	2026	—

FIG. 1 — Lineage of K253673, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LQK device

#1 K210025 INVU by Nuvoscore 5.0 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K143114	Sense4Baby System Model B+ (MSA) Summary page 5 …gulation Number: 21 CFR 884.2730 Product Code: LQK (Home Uterine Activity Monitor) Device Class: II Predicate Device: K143114 Sense4Baby System, Model B+ (MSA) Device Description The M•care System is a device-enabled softwa…	Airstrip Technologies, Inc.	2015	1

Also cleared against K143114: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K143114.

How does its category compare?

All LQK devices

LQK Home Uterine Activity Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · LQK

1in 2022

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQK

Too few LQK 510(k)s in any year since 2007 to give a median.

Recalls per year · LQK

No recall names LQK since 2007.

Adverse event reports per year · LQK

No MAUDE report names LQK since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	1	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The Mecare System is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and patient-reported fetal movements. The Mecare System acquires and displays the FHR and MHR tracings from abdominal surface electrodes that pick up the fetal heart biopotential and maternal heart biopotential signals. The Mecare System is indicated for use by pregnant women who need documentation of fetal heart rate…

Read the full statement (172 words)

The Mecare System is indicated for use by pregnant women who need documentation of fetal heart rate activity, and who are in their 32nd week of gestation (or later) with a singleton pregnancy. The Mecare System is intended to be used for a maximum of five minutes.

The Mecare System is intended for use in the antepartum period by healthcare professionals in health care facilities and by the patient in the patient’s home, on the order of a physician.

The Mecare System is not intended for use in critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor.

The Mecare System is not intended to be used for antepartum monitoring (e.g., non-stress testing).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K253673 · printed Nov 4, 2026

Cite this page

510(k) Report. “K253673: M•care System (MW-20).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253673

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026