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Monica IF24 Uterine Electromyographic Monitor

by Monica Healthcare

510(k) K112163

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112163 Date30 Aug 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1293-2018 FDA Class II initiated 15 Dec 2017

    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).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Monica IF24
510(k) Number
FDA Product Code
OSP
Device Class
Class II
Regulation
21 CFR Part 884.2720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Monica IF24 is a Uterine Electromyographic Monitor, designed to record and display uterine electrical activity during pregnancy. It provides real-time data on contractions, enabling clinicians to assess labor progression, fetal well-being, and potential complications such as preterm labor or dystocia. The device is classified under the Obstetrics/Gynecology specialty and is intended for use in clinical settings where continuous monitoring of uterine activity is required.

The Monica IF24 is supplied as a Class 2 medical device and is substantially equivalent to its predecessor, as determined by the FDA 510(k) clearance process (K112163). It functions as an interface accessory, connecting wirelessly to the Monica AN24 fetal monitor to facilitate contraction monitoring. The device is not sterile and is intended for reusable use in controlled clinical environments. No specific MRI safety information is provided, and its regulatory status is confirmed by the FDA’s 510(k) clearance under the Obstetrics/Gynecology advisory committee.

Other devices from Monica Healthcare

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is the Monica IF24 Uterine Electromyographic Monitor primarily used for during pregnancy?

    The Monica IF24 is designed to continuously monitor uterine electrical activity, enabling clinicians to assess labor progression, fetal well-being, and potential complications such as preterm labor or dystocia. It provides real-time contraction data, making it particularly useful in clinical settings where ongoing evaluation of uterine activity is critical, like labor and delivery units or high-risk pregnancy care.

  • How is the Monica IF24 supplied and intended for use in a clinical environment?

    The Monica IF24 is supplied as a reusable Class 2 medical device and is not sterile. It is intended for use in controlled clinical environments where proper cleaning and maintenance protocols can be followed. The device connects wirelessly to the Monica AN24 fetal monitor, serving as an interface accessory for contraction monitoring.

  • What regulatory pathway was followed for the FDA clearance of the Monica IF24?

    The Monica IF24 received FDA clearance through a Traditional 510(k) process, specifically under the Obstetrics/Gynecology advisory committee. It was determined to be substantially equivalent to its predecessor, as confirmed by the FDA’s clearance (K112163). This classification aligns with its role as a uterine electromyographic monitor for clinical use.

  • Is the Monica IF24 compatible with MRI environments, and what safety considerations should be noted?

    The Monica IF24 does not provide specific MRI safety information in its documentation. Clinicians should exercise caution and verify compatibility with their MRI systems before use in such environments to avoid potential interference or safety risks.