510(k) · Cleared
ClearedINVU by Nuvo
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 May 28, 2021 as substantially equivalent to K143114 (Airstrip Technologies, Inc., 2015) after a 144-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- May 28, 2021
- Review
- 144 days
- Class
- Class II
- Product code
- LQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002548 (2001). 1 later device descends from it, 1 citing it directly.
- 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 deviceK210025 INVU by NuvoNuvo- Group, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK221046 Invu by NuvoNuvo- Group, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221046Invu by NuvoNuvo- Group, Ltd. · 2022 · cites it directly0descendants
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) | K210025 | INVU by Nuvo | Nuvo- Group, Ltd. | 2021 | — |
| +1 | K221046 | Invu by Nuvo | Nuvo- Group, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 12.5 · 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 INVU by Nuvo™ is a… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221046 | Invu by Nuvo | 2022 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K221046 (Nuvo- Group, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 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. 2021, 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?
INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA). The INVU Sensor BandTM acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from…
Read the full statement (155 words)
INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).
The INVU Sensor BandTM acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy.
The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient’s home, on the order of a physician.
The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).
This system does not 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/K210025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210025: INVU by Nuvo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210025
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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