510(k) · Cleared
ClearedPregSense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvo- Group, Ltd. · LQK Home Uterine Activity Monitor
Cleared on Mar 27, 2020 as substantially equivalent to K143114 (Airstrip Technologies, Inc., 2015) after a 308-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Mar 27, 2020
- Review
- 308 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.
- 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 deviceK191401 PregSenseNuvo- Group, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
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 K253673 M•care System (MW-20)score 12.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K143114 | Sense4Baby System Model B+ (MSA)Summary page 4…ame: Home Uterine Activity Monitor Product Code: LQK Product Code Name: Home Uterine Activity Monitor Regulatory Class: II Predicate Device: Sense4Baby System Model B+ (K143114). The predicate device has been subject to a design-related recall (belt clip defects). Device Description PregSense™ is a non-i… | 2015 |
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 19 years and passes through 3 companies; a new generation was cleared every 5.0 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 devicesLQK Home Uterine Activity Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LQK
1in 2022
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PregSense is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR). The PregSense acquires and displays the FHR and MHR tracings from abdominal surface electrodes that pick up the fetal heart biopotential and maternal heart biopotential signal, and from surface acoustic sensors that pick up the fetal PCG (fPCG; phonocardiogram) and the maternal PCG (mPCG; phonocardiogram) signals.…
Read the full statement (180 words)
PregSense is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR). The PregSense acquires and displays the FHR and MHR tracings from abdominal surface electrodes that pick up the fetal heart biopotential and maternal heart biopotential signal, and from surface acoustic sensors that pick up the fetal PCG (fPCG; phonocardiogram) and the maternal PCG (mPCG; phonocardiogram) signals.
PregSense 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. PregSense is intended to be used for a maximum of five minutes.
The PregSense maternal-fetal monitor 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 PregSense is not intended for use in critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor.
PregSense is not intended to be used for antepartum monitoring (e.g., non-stress testing).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191401: PregSense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191401
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026