510(k) · Cleared
Recalled · Class II · 2017Monica Novii Wireless Patch System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monica Healthcare, Ltd. · OSP Uterine Electromyographic Monitor
Cleared on Aug 27, 2014 as substantially equivalent to K101801 (Monica Healthcare, 2011) and 3 other predicates after a 146-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 27, 2014
- Review
- 146 days
- Class
- Class II
- Product code
- OSP
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K894277 (1989). 18 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
- 4 generations backK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
- 3 generations backK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
- 2 generations backK023931 Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A…Philips Medical Systems, Inc. · 2003
- 1 generation backK112163 Monica IF24Monica Healthcare · 2011 · Recalled
- This deviceK140862 Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK231964 Novii+ Wireless Patch SystemDatex Ohmeda · 2023
- Descendant · 2 generations on · 0 of its ownK254036 Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK233440 Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal &…Philips Medizin Systeme Boeblingen GmbH · 2024
Most influential descendants
Showing 3 of 3 · See all- K231964Novii+ Wireless Patch SystemDatex Ohmeda · 2023 · cites it directly1descendant
- K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026 · 2 generations on0descendants
- K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…Philips Medizin Systeme Boeblingen GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894277 | M1400A Transmitter,M1402 Receiver,M1401 Mainframe | Hewlett-Packard Co. | 1989 | — |
| −4 | K980429 | HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care… | Hewlett-Packard Co. | 1998 | — |
| −3 | K993516 | HP M2600A Viridia Telemetry System | Hewlett-Packard Co. | 1999 | — |
| −2 | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A… | Philips Medical Systems, Inc. | 2003 | — |
| −1 | K112163 | Monica IF24 | Monica Healthcare | 2011 | 1 |
| 0 (this device) | K140862 | Monica Novii Wireless Patch System | Monica Healthcare, Ltd. | 2014 | — |
| +1 | K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023 | — |
| +2 | K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026 | — |
| +1 | K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal… | Philips Medizin Systeme Boeblingen GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K101801 | Monica AN24Summary page 4…25th July 2014 Classification Name: 21 CFR 884.270 System Monitoring Perinatal Predicate Device: Monica AN24 (K101801, K112390) Monica IF24 (K112163) Ambu… | 2011 |
| * | K112390 | Monica AN24Summary page 4…July 2014 Classification Name: 21 CFR 884.270 System Monitoring Perinatal Predicate Device: Monica AN24 (K101801, K112390) Monica IF24 (K112163) Ambu Electrode… | 2012 |
| * | K112163 | Monica IF24Summary page 4….270 System Monitoring Perinatal Predicate Device: Monica AN24 (K101801, K112390) Monica IF24 (K112163) Ambu Electrodes (K041026) Device Description: The Monica Novii Pod Fetal-Materna… | 2011 |
| * | K041026 | Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-SSummary page 4…Monica AN24 (K101801, K112390) Monica IF24 (K112163) Ambu Electrodes (K041026) Device Description: The Monica Novii Pod Fetal-Maternal Monitor is designed as an ambulatory device for the monitoring of a pr… | 2004 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Dec 15, 2017 | Class II | Z-1292-2018 | Device Design | if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped). |
| Apr 28, 2017 | Class II | Z-2588-2017 | Nonconforming Material/Component | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K231964 (Datex Ohmeda, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K101801.
How does its category compare?
All OSP devicesOSP Uterine Electromyographic Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR…
Read the full statement (210 words)
The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
The Novii Patch is an accessory to the Novii Pod that connects directly to the Novii Pod and contains the surface electrodes that attach to the abdomen.
The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
The Novii Pod maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140862: Monica Novii Wireless Patch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140862
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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