510(k) · Cleared
Recalled · Class II · 2017Monica IF24
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 Aug 30, 2011 as substantially equivalent to K101801 (Monica Healthcare, 2011) and 1 other predicate after a 34-day review. Its family tree reaches back 4 generations to 1989. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 30, 2011
- Review
- 34 days
- Class
- Class II
- Product code
- OSP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894277 (1989). 14 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
- 3 generations backK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
- 2 generations backK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
- 1 generation backK023931 Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A…Philips Medical Systems, Inc. · 2003
- This deviceK112163 Monica IF24Monica Healthcare · 2011
- 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 · 3 generations on · 0 of its ownK254036 Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
- Descendant · 2 generations on · 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 4 of 4 · See all- K140862Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · cites it directly3descendants
- K231964Novii+ Wireless Patch SystemDatex Ohmeda · 2023 · 2 generations on1descendant
- K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026 · 3 generations on0descendants
- K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…Philips Medizin Systeme Boeblingen GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894277 | M1400A Transmitter,M1402 Receiver,M1401 Mainframe | Hewlett-Packard Co. | 1989 | — |
| −3 | K980429 | HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care… | Hewlett-Packard Co. | 1998 | — |
| −2 | K993516 | HP M2600A Viridia Telemetry System | Hewlett-Packard Co. | 1999 | — |
| −1 | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A… | Philips Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K112163 | Monica IF24 | Monica Healthcare | 2011 | — |
| +1 | K140862 | Monica Novii Wireless Patch System | Monica Healthcare, Ltd. | 2014 | 2 |
| +2 | K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023 | — |
| +3 | K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026 | — |
| +2 | 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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (2)
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 1…fSummary: 12 August 2011 Classification Name: 21, CFR 884.2740 System Monitoring Perinatal Product Code: OSP Secondary Product Code: HGM Predicate Device: Monica AN24 (K101801) Philips Avalon CTS (K023931) Reason for 510(K): This 510(K) is to add the Monica I1F24 Interface device as an… | 2011 |
| * | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727ASummary page 1…1, CFR 884.2740 System Monitoring Perinatal Product Code: OSP Secondary Product Code: HGM Predicate Device: Monica AN24 (K101801) Philips Avalon CTS (K023931) Reason for 510(K): This 510(K) is to add the Monica I1F24 Interface device as an accessory to the Monica AN24 Fetal Monitor prev… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140862 | Monica Novii Wireless Patch System | 2014 | 3 |
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-1293-2018 | Device Design | if the cables of the Monica IF24 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). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K140862 (Monica Healthcare, Ltd., 2014) has gone furthest, with 3 descendants 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. 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 IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112163: Monica IF24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112163
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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