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 6, 2022 as substantially equivalent to K210025 (Nuvo- Group, Ltd., 2021) after a 28-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 6, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- LQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002548 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK002548 Fetal AssistHuntleigh Diagnostics, Ltd. · 2001
- 3 generations backK020390 Modification to Fetal AssistHuntleigh Diagnostics, Ltd. · 2002
- 2 generations backK143114 Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 2015 · Recalled
- 1 generation backK210025 INVU by NuvoNuvo- Group, Ltd. · 2021
- This deviceK221046 Invu by NuvoNuvo- Group, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002548 | Fetal Assist | Huntleigh Diagnostics, Ltd. | 2001 | — |
| −3 | K020390 | Modification to Fetal Assist | Huntleigh Diagnostics, Ltd. | 2002 | — |
| −2 | K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | 2015 | 1 |
| −1 | K210025 | INVU by Nuvo | Nuvo- Group, Ltd. | 2021 | — |
| 0 (this device) | K221046 | Invu by Nuvo | Nuvo- Group, Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K210025 | INVU by NuvoSummary page 4…Product Code LQK (Home Uterine Activity Monitor) Classification Panel Obstetrics/Gynecology Regulatory Class II Predicate Device K210025 INVU by Nuvo™ The predicate device has not been subject to a design-related recall. Device Description INVU by Nuv… | 2021 |
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 21 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LQK devicesLQK Home Uterine Activity Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Band™ 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…
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 Band™ 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/K221046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221046: Invu by Nuvo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221046
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