510(k) · Cleared
Recalled · Class II · 2016Sense4Baby System Model B+ (MSA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airstrip Technologies, Inc. · LQK Home Uterine Activity Monitor
Cleared on Mar 10, 2015 as substantially equivalent to K020390 (Huntleigh Diagnostics, Ltd., 2002) after a 131-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 10, 2015
- Review
- 131 days
- Class
- Class II
- Product code
- LQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002548 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002548 Fetal AssistHuntleigh Diagnostics, Ltd. · 2001
- 1 generation backK020390 Modification to Fetal AssistHuntleigh Diagnostics, Ltd. · 2002
- This deviceK143114 Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK210025 INVU by NuvoNuvo- Group, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK253673 M•care System (MW-20)Marani Health, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK221046 Invu by NuvoNuvo- Group, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK191401 PregSenseNuvo- Group, Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K210025INVU by NuvoNuvo- Group, Ltd. · 2021 · cites it directly1descendant
- K253673M•care System (MW-20)Marani Health, Inc. · 2026 · cites it directly0descendants
- K221046Invu by NuvoNuvo- Group, Ltd. · 2022 · 2 generations on0descendants
- K191401PregSenseNuvo- Group, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002548 | Fetal Assist | Huntleigh Diagnostics, Ltd. | 2001 | — |
| −1 | K020390 | Modification to Fetal Assist | Huntleigh Diagnostics, Ltd. | 2002 | — |
| 0 (this device) | K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | 2015 | — |
| +1 | K210025 | INVU by Nuvo | Nuvo- Group, Ltd. | 2021 | — |
| +1 | K253673 | M•care System (MW-20) | Marani Health, Inc. | 2026 | — |
| +2 | K221046 | Invu by Nuvo | Nuvo- Group, Ltd. | 2022 | — |
| +1 | K191401 | PregSense | Nuvo- Group, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
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 12.6 · 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 |
|---|---|---|---|
| * | K020390 | Modification to Fetal AssistSummary page 4…ty Monitor Product Code: LQK, MOH, HGM Regulation: 21 CFR 884.2730 Substantial equivalence claimed to: Huntliegh Healthcare Limited Fetal Assist, K020390 1.1. Description: The Sense4Baby System, Model B+ (MSA) is a non-invasive, wireless, external monitoring system used to measure… | 2002 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2016 | Class II | Z-2829-2016 | Nonconforming Material/Component | Belt clip may become detached causing electronic components to be exposed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210025 (Nuvo- Group, Ltd., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LQK devicesLQK Home Uterine Activity Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143114 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143114: Sense4Baby System Model B+ (MSA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143114
Report an extraction error
Are you the manufacturer?
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