510(k) · Cleared
ClearedMonica AN24
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monica Healthcare · OSP Uterine Electromyographic Monitor
Cleared on Feb 3, 2011 as substantially equivalent to K954351 (Hewlett-Packard GmbH, 1996) after a 220-day review. Its family tree reaches back 2 generations to 1990. 8 later devices descend from it.
- Decided
- Feb 3, 2011
- Review
- 220 days
- Class
- Class II
- Product code
- OSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900480 (1990). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK900480 M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co. · 1990
- 1 generation backK954351 Series 50XMHewlett-Packard GmbH · 1996
- This deviceK101801 Monica AN24Monica Healthcare · 2011
- Descendant · cites it directly · 4 of its ownK112163 Monica IF24Monica Healthcare · 2011 · Recalled
- Descendant · cites it directly · 3 of its ownK140862 Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK231964 Novii+ Wireless Patch SystemDatex Ohmeda · 2023
- Descendant · cites it directly · 1 of its ownK120018 Mindchild Meridian Fetal Heart Rate MonitorMindchild Medical · 2012
- Descendant · 3 generations on · 0 of its ownK254036 Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K112163Monica IF24Monica Healthcare · 2011 · cites it directly4descendants
- K140862Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · cites it directly3descendants
- K231964Novii+ Wireless Patch SystemDatex Ohmeda · 2023 · 2 generations on1descendant
- K120018Mindchild Meridian Fetal Heart Rate MonitorMindchild Medical · 2012 · cites it directly1descendant
- K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900480 | M1350A Fetal Monitor (Intrapartum) | Hewlett-Packard Co. | 1990 | — |
| −1 | K954351 | Series 50XM | Hewlett-Packard GmbH | 1996 | — |
| 0 (this device) | K101801 | Monica AN24 | Monica Healthcare | 2011 | — |
| +1 | K112163 | Monica IF24 | Monica Healthcare | 2011 | 1 |
| +1 | K140862 | Monica Novii Wireless Patch System | Monica Healthcare, Ltd. | 2014 | 2 |
| +2 | K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023 | — |
| +1 | K120018 | Mindchild Meridian Fetal Heart Rate Monitor | Mindchild Medical | 2012 | — |
| +3 | K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 OSP? 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 OSP device
- #1 K190798 LaborView™ LV1000 Wireless Electrode Systemscore 0.9 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K954351 | Series 50XMSummary page 1…1GF UK Date of Summary: 4"s January 2011I Classification Name: 21 CFR 884.270 System Monitoring Perinatal Predicate Device: Philips 5OXM (K954351) Device Description: The Monica AN24 TM is a small, battery-powered device for L&D surveillance of fetal well-being. The A… | 1996 |
What descends from it? (8)
4 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)
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 14.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112163 (Monica Healthcare, 2011) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K954351.
How does its category compare?
All OSP devicesOSP Uterine Electromyographic Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OSP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OSP
220in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSP
No recall names OSP since 2007.
Adverse event reports per year · OSP
1in 2025
MAUDE reports naming product code OSP, not matched to any one device; reports are not rates.
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 | 3 | 220 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Monica AN24 is an intrapartumn maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and uterine activity (UA). The AN24 acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal EGG (fECG) signal. Using the same surface electrodes, the AN24 also acquires and displays the UA tracing from the uterine electromyography (EMG) signal. The AN24 is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
The AN24 maternal-fetal monitor is intended for use by healthcare professionals in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101801: Monica AN24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101801
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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