M•care System (MW-20)
Device Facts
| Record ID | K253673 |
|---|---|
| Device Name | M•care System (MW-20) |
| Applicant | Marani Health, Inc. |
| Product Code | LQK · Obstetrics/Gynecology |
| Decision Date | Sep 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2730 |
| Device Class | Class 2 |
Indications for Use
The M•care 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 M•care 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 M•care 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 M•care System is intended to be used for a maximum of five minutes. The M•care 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 M•care 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 M•care System is not intended to be used for antepartum monitoring (e.g., non-stress testing).
Device Story
M•care System (MW-20) is a remote antenatal monitoring platform; collects maternal and fetal biopotential signals via abdominal surface electrodes embedded in M•wrap; transmits data via Bluetooth to mobile app; signals processed via cloud/network pipeline to extract FHR and MHR; results displayed on mobile app for patient and provider portal for clinicians; used in home or clinical settings; 5-minute monitoring sessions prescribed by physician; enables patient-reported fetal movement tracking; provides objective heart rate data to support clinical decision-making; non-invasive; benefits include remote access to fetal/maternal heart rate monitoring.
Clinical Evidence
Two studies: feasibility (n=57 sessions, 26 subjects) and pivotal (n=120 subjects). Pivotal study was a prospective paired comparison against standard CTG. Primary endpoints: FHR and MHR accuracy. FHR mean bias 0.41 BPM (95% CI: 0.25, 0.59); MHR mean bias 0.26 BPM (95% CI: 0.12, 0.37). Deming regression showed minimal bias. Safety: 0.8% adverse event rate (erythema/irritation). Summative usability study (n=15) confirmed safe home use.
Technological Characteristics
Surface biopotential electrodes; Bluetooth connectivity to mobile device; cloud-based signal processing; iOS/Android app interface; provider web portal; battery-powered; non-invasive; biocompatibility per ISO 10993-5, -10, -23; electrical safety per IEC 60601-1/1-11; wireless coexistence per IEEE C63.27.
Indications for Use
Indicated for pregnant women ≥ 32 weeks gestation with singleton pregnancy needing fetal heart rate documentation. Not for critical care, laboring patients, patients hospitalized for/suspected of preterm labor, or non-stress testing.
Regulatory Classification
Identification
A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.
Special Controls
*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Predicate Devices
- Sense4Baby System, Model B+ (K143114)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 3, 2026
Marani Health, Inc.
Mindy Ditch, MS
Vice President, Clinical & Regulatory Affairs
3510 Hopkins Place N.
Oakdale, Minnesota 55128
Re: K253673
Trade/Device Name: M-care System (MW-20)
Regulation Number: 21 CFR 884.2730
Regulation Name: Home Uterine Activity Monitor
Regulatory Class: Class II
Product Code: LQK
Dated: August 5, 2026
Received: August 5, 2026
Dear Mindy Ditch:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K253673
Device Name
M•care System (MW-20)
Indications for Use (Describe)
The M•care 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 M•care 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 M•care 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 M•care System is intended to be used for a maximum of five minutes.
The M•care 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 M•care 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 M•care System is not intended to be used for antepartum monitoring (e.g., non-stress testing).
Type of Use (Select one or both, as applicable)
☑
Prescription Use (Part 21 CFR 801 Subpart D)
☐
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
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K253673 – 510(k) Summary
M•care System
MARANI
# **510(k) Summary – K253673**
In accordance with 21 CFR 807.92 the following summary information is provided:
| **Submitter:** | Marani Health, Inc. 3510 Hopkins Place North Oakdale, MN 55128 651-340-5205 |
| --- | --- |
| **Contact Person:** | Mindy Ditch Vice President, Clinical & Regulatory Affairs mindy@maranihealth.com |
| **Date Prepared:** | September 3, 2026 |
| **Trade Name:** | M•care System (MW-20) |
| **Common Name:** | Home Uterine Activity Monitor |
| **Regulation Name:** | Home Uterine Activity Monitor |
| **Regulation 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 software platform intended for the remote antenatal monitoring of pregnant women. It is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and of the fetus for a maximum of five minutes. It collects and processes signals collected by biopotential sensors that contact the abdominal surface. These sensors are embedded in the patient-contacting component, the M•wrap, which is wrapped around the abdomen. The sensors are electrodes that collect biopotential signals (electrical activity) which are transmitted via Bluetooth to the user's mobile device (iOS or Android) using the M•wrap App. These signals are then sent via Wi-Fi or cellular network to the M•wrap Signal Processing pipeline to extract MHR and FHR. After processing, the average FHR and MHR results are viewable by the patient via the M•wrap App, and full heart rate traces are viewable by healthcare providers via the M•care Provider Portal.
HCPs prescribe the M•care System for pregnant women who are at 32 weeks or greater in gestation with a singleton pregnancy. HCPs prescribe monitoring sessions to be completed by
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K253673 – 510(k) Summary
M•care System
MARANI
the patient to collect fetal/maternal heart rate data for viewing by the HCP. During a 5-minute monitoring session, patients are also able to record fetal movements (kicks) in the M•wrap App. The M•care System is not intended for the monitoring sessions to be repeated successively; monitoring sessions must be prescribed by the HCP via the M•care Provider Portal and must be completed by the patient within a scheduled window of time. Monitoring sessions are able to be performed remotely by the patient or may be performed in a clinical setting with support from clinicians.
The M•care System is used in the following operations:
Preparation:
- Charging the M•core
- Installation of the M•wrap App
- Account creation
- Patient training
- Installation of M•core in M•wrap
- Placement of M•wrap on abdomen
Use:
- Logging in to the M•wrap App
- Viewing prescribed monitoring sessions
- Pairing of M•wrap to mobile device via Bluetooth
- Checking for software update(s)
- Initialization and warm-up period (5 minutes) to ensure the sensors within the M•wrap have sufficient contact with the abdominal skin and sufficient fetal heart rate signal quality
- Complete prescribed monitoring session (5 minutes) to collect fetal heart rate, maternal heart rate and patient-reported fetal movements (kicks)
After the user pairs the M•wrap to their mobile device and initiates a prescribed session, the monitoring session begins with a 5-minute initialization and warm-up period. The monitoring session begins immediately following and proceeds for a duration of 5 minutes.
# Indications for Use
The M•care 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 M•care 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 M•care 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 M•care System is intended to be used for a maximum of five minutes.
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K253673 – 510(k) Summary
M•care System
[LOGO]
MARANI
The M•care 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 M•care 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 M•care System is not intended to be used for antepartum monitoring (e.g., non-stress testing).
## Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Device
The table below compares the technological characteristics of the subject and predicate devices.
| | **Subject Device: M•care System** | **Predicate Device: Sense4Baby System Model B+** |
| --- | --- | --- |
| 510(k) Number | K253673 | K143114 |
| Product Code | LQK | LQK, MOH, HGM |
| Device Type | Maternal-fetal monitor | Maternal-fetal monitor |
| Prescription use | Medical personnel or patients on the order of physician | Medical personnel or patients on the order of physician |
| Indications for Use | The M•care 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 M•care 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 M•care System is indicated for use by pregnant women who need documentation of fetal | The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home. It is to be used by health care professionals and patients on the order of a physician. |
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M•care System
| | heart rate activity, and who are in their 32nd week of gestation (or later) with a singleton pregnancy. The M•care System is intended to be used for a maximum of five minutes. The M•care 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 M•care 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 M•care System is not intended to be used for antepartum monitoring (e.g., non-stress testing). | Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment. Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth. |
| --- | --- | --- |
| Intended Environments | Health care setting or home | Health care setting or home |
| Target Population | Women ≥ 32 weeks gestation with singleton pregnancy | Women ≥ 24 weeks gestation |
| Patient Interface | Surface ECG bio-potential sensor | Maternal abdomen connected to sensor with Piezo-electric crystals |
| Data Collected from Sensor Array | Fetal heart rate, maternal heart rate | Fetal heart rate, maternal heart rate, uterine activity |
| Technology Employed | Transabdominal biopotential signals | Pulsed doppler ultrasound |
| Monitoring session | 5 minutes | 30 minutes |
| Information displayed on | Cloud or mobile-based software applications | Web based portal |
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K253673 – 510(k) Summary
M•care System
MARANI
Both the M•care System and the predicate device are indicated for monitoring of fetal and maternal health signals in a health care facility setting or the patient's home on the order of a physician. Although the M•care System is indicated for women at 32 weeks of gestation or later, as opposed to 24 weeks of gestation or later for the predicate device, this does not alter the intended use because the intended use population for the M•care System is a subset of the intended use population for the predicate device. The monitoring of fetal heart rate (FHR) and maternal heart rate (MHR) is the same regardless of the gestational age at onset of use of the device. Apart from the difference in the time point within the antenatal stage when patients may begin using the device, the intended patient populations are the same.
The M•care System measures FHR and MHR. Although the predicate device additionally measures uterine activity (UA), which the M•care System does not, this difference does not result in a new intended use because both devices measure FHR and MHR. Thus, while the indications for use are slightly different between the M•care System and the predicate device, these differences do not raise different questions of safety and effectiveness.
The M•care System has similar technological characteristics to the predicate device. The new device and predicate device share important general technological characteristics. The M•care System and the predicate device are both wireless devices that non-invasively measure physiological signals using surface sensors to perform their intended use. The difference between the two devices is that the M•care System acquires biopotential signals from sensors whereas the predicate device uses Pulsed Doppler Ultrasound signals.
While differences in technological characteristics are identified, these differences do not raise different questions of safety and effectiveness.
## Non-Clinical Performance Data
The development and testing of the M•care System was in accordance with the FDA Special Controls Guidance for Home Uterine Activity Monitors (issued March 9, 2001) and the following non-clinical testing was provided to support a determination of substantial equivalence for the M•care System. The testing was completed as part of the verification and validation of the M•care System that provided objective evidence that specified design requirements have been fulfilled:
- Use life testing to support 10 weeks of use:
- Mechanical Connection Performance Testing
- Electrical Connection Performance Testing
- Mechanical testing as follows:
- Transmit and Climatic Conditioning testing (ASTM D4169)
- Compression Testing
- Mechanical Functionality (including cycle testing)
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- Material Compatibility and Cleaning Verification (Non-Biocompatibility)
- Size Analysis Verification
- Labeling Verification
• Electrical testing as follows:
- PCBA Testing
- Electrical Connection Testing
- Electrode Performance Testing
- Signal Acquisition Verification Testing
- User Interface Verification Testing
- Service Life Verification
- Device Disposal Verification (California Electronic Waste Recycling Act of 2003)
- IFU Reading Level Verification
- Electromagnetic Testing (IEC 60601-1-2)
- Electrical Safety Testing (IEC 60601-1 and IEC 60601-1-11)
- Battery Safety Testing (IEC 62133-2)
- Wireless Coexistence Testing (IEEANSI C63.27)
- FCC Part 15 Subpart B and FCC Part 15 Subpart C (per KDB996369 D04 Module Integration Guide)
• Software testing as follows:
- M•wrap Mobile Application Software Verification
- M•care Provider Portal Software Verification
- M•care System Algorithm Software Verification
- M•care System Algorithm Preprocessing Software Verification
- M•care System Cybersecurity Verification
Software documentation was provided in accordance with the 2023 FDA guidance document, Content of Premarket Submissions for Device Software Functions.
Cybersecurity information was provided in accordance with the 2025 FDA guidance document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
• Firmware Testing
• M•care System End-to-End Software Validation
• Biocompatibility testing was executed per the recommendations of FDA Guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” as follows:
- Cytotoxicity – ISO 10993-5
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MARANI
- Sensitization – ISO 10993-10
- Irritation – ISO 10993-23
- Human Factors testing was executed per the recommendations of the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016), IEC 60601-1-6, and IEC 62366-1.
- The device was tested and demonstrated to be safe in case of defibrillation.
### Clinical Performance Data
Two clinical studies were performed using the M•care System for analysis: a feasibility study and a pivotal study. The feasibility study was conducted to establish the feasibility of the M•care System. The objective of the pivotal study was to demonstrate the safety and performance of the M•care System.
The feasibility study was a single-center, open label, non-randomized study conducted in the US. A total of 57 monitoring sessions from 26 unique subjects were included. The study population consisted of adult female subjects with a singleton pregnancy, who were greater than or equal to 28 weeks of gestation, and had a pre-pregnancy body mass index (BMI) between 15 and 45 kg/m². The median age of subjects was 31.0 years. Not Hispanic or Latino ethnicity accounted for 87.7% of subjects, and 91.2% of subjects reported White race. No adverse events were reported in the study. The results of the study demonstrated the feasibility of the device, the ability to concurrently collect data from the study device and control and supported continued evaluation of the M•care System through initiation of the pivotal study.
The pivotal study was a multi-center, open label, non-randomized, prospective paired comparison trial intended to establish the equivalence of the M•care System to an FDA-cleared Cardiotocography (CTG) device. A total of 120 adult subjects with singleton pregnancies, gestational age greater than or equal to 32 weeks, and pre-pregnancy BMI between 15 and 45 kg/m² were included. Subjects were enrolled at three US study sites across two study settings, Antenatal and Enriched Hospital, which were utilized to ensure collection of the range of gestational ages included in the product label claim. All 120 enrolled subjects were included in the Safety Population, while 93 subjects were included in the Performance Evaluable (PE) Population. The median age of subjects in the PE Population was 32.0 years. Not Hispanic or Latino ethnicity accounted for 94.4% of subjects, and 80.6% of subjects reported White race.
The primary performance measures in the pivotal study were fetal heart rate (FHR) and maternal heart rate (MHR) as measured by the M•care System versus standard of care CTG device. FHR results show a mean difference (bias) of 0.41 BPM (SD = 4.19, 95% CI: 0.25, 0.59) for the M•care System. Using Bland-Altman Limits of Agreement (LOA), the 95% LOA are –7.8 and 8.61 BPM. MHR results demonstrate a mean difference (bias) of 0.26 BPM (SD=2.69, CI: 0.12, 0.37) for the M•care System, and the 95% LOA are –5.02 and 5.53 BPM. Deming regressions for both FHR and MHR supported these results with slope parameter estimates of 1
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MARANI
and intercepts near 0, indicating minimal proportional and fixed bias, respectively. Overall, consistent results were seen across subgroups for body mass index (BMI), study group, race, study site, gestational age, M•wrap size, history of obstetrical complications, and placental position. Deming regression subgroup analyses were supportive of these results.
A single mild adverse event for erythema and irritation occurred in one of 120 (0.8%) subjects in the safety population, which was caused by the exfoliating agent prior to placement of the M•wrap. No serious adverse events occurred in the pivotal study.
Because the standard of care CTG monitoring device could not be used in a home environment, a summative usability study with 15 subjects was performed to ensure the device performs appropriately when used by patients at home. The results of this usability study indicate that the patient-facing user interface components of the M•care System are safe and effective for use.
## Conclusion
The results of the performance testing described above demonstrate that the M•care System is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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