510(k) · Cleared
ClearedModification to Fetal Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Diagnostics, Ltd. · LQK Home Uterine Activity Monitor
Cleared on Apr 19, 2002 as substantially equivalent to K002548 (Huntleigh Diagnostics, Ltd., 2001) after a 72-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Apr 19, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- LQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002548 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002548 Fetal AssistHuntleigh Diagnostics, Ltd. · 2001
- This deviceK020390 Modification to Fetal AssistHuntleigh Diagnostics, Ltd. · 2002
- Descendant · cites it directly · 4 of its ownK143114 Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK210025 INVU by NuvoNuvo- Group, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK253673 M•care System (MW-20)Marani Health, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK221046 Invu by NuvoNuvo- Group, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK191401 PregSenseNuvo- Group, Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K143114Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 2015 · cites it directly4descendants
- K210025INVU by NuvoNuvo- Group, Ltd. · 2021 · 2 generations on1descendant
- K253673M•care System (MW-20)Marani Health, Inc. · 2026 · 2 generations on0descendants
- K221046Invu by NuvoNuvo- Group, Ltd. · 2022 · 3 generations on0descendants
- K191401PregSenseNuvo- Group, Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002548 | Fetal Assist | Huntleigh Diagnostics, Ltd. | 2001 | — |
| 0 (this device) | K020390 | Modification to Fetal Assist | Huntleigh Diagnostics, Ltd. | 2002 | — |
| +1 | K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | 2015 | 1 |
| +2 | K210025 | INVU by Nuvo | Nuvo- Group, Ltd. | 2021 | — |
| +2 | K253673 | M•care System (MW-20) | Marani Health, Inc. | 2026 | — |
| +3 | K221046 | Invu by Nuvo | Nuvo- Group, Ltd. | 2022 | — |
| +2 | K191401 | PregSense | Nuvo- Group, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 12.5 · 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 |
|---|---|---|---|
| * | K002548 | Fetal AssistSummary page 1…Mow | for. "Z J’-jntw AMe Fetartitrasenie-Monitor and Accessories (21 CFR § 884.2680) Home Uterine Activity Monitors (21 CFR § 884.2730) Predicate Devices FETAL ASSIST (K002548) Doc Ne: 709 1023 Page 7 of 12 Huntleigh Diagnostics K0203T0 prggzel= Device Description The FETAL ASSIST is a… | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143114 | Sense4Baby System Model B+ (MSA) | 2015 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K143114 (Airstrip Technologies, Inc., 2015) has gone furthest, with 4 descendants 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.
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 FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications from a gestation age of approximately 26 weeks. It is particularly intended for use in the following specific areas:
Antenatal monitoring in the hospital, doctors office, health clinic, home or community.
External Labour monitoring.
Waterbirth monitoring using optional waterproof transducers.
Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the daily at-home measurement of uterine activity for women with a history of preterm birth.
Domiciliary Non Stress Testing applications.
The FETAL ASSIST is a prescription device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020390: Modification to Fetal Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020390
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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