# K112163: Monica IF24

- Pathway: 510(k) (Traditional)
- Applicant: Monica Healthcare
- Decided: Aug 30, 2011 after 34 days
- Product code: OSP (Uterine Electromyographic Monitor)
- Device class: 2
- Regulation: 21 CFR 884.2720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894277 (1989). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101801: Monica AN24, Monica Healthcare (2011) Summary page 1.
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A, Philips Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K140862: Monica Novii Wireless Patch System (2014), 3 descendants of its own
- K231964: Novii+ Wireless Patch System (2023), 1 descendant of its own
- K254036: Novii+ Wireless Patch System (2026), 0 descendants of its own
- K233440: Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (2024), 0 descendants of its own

## Recalls of this device
- Dec 15, 2017 · Class II · Z-1293-2018: 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 (swappe

## Indications for use
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.

Source page: https://510kreport.com/device/K112163
Methodology: https://510kreport.com/methodology