Cleared Traditional

K231964 - Novii+ Wireless Patch System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K231964 · Datex-Ohmeda · Obstetrics & Gynecology device
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Dec 2023
Decision
158d
Days
Class 2
Risk

K231964 is an FDA 510(k) clearance for the Novii+ Wireless Patch System. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Datex-Ohmeda (Wauwatosa, US). The FDA issued a Cleared decision on December 8, 2023 after a review of 158 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Ohmeda devices

Submission Details

510(k) Number K231964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date December 08, 2023
Days to Decision 158 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 160d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03057275 Completed Observational Industry-sponsored

Performance of the Monica Novii Wireless Patch System in Pre-term Labor

47
Patients (actual)
1
Site
Condition studied Premature Labor
Eligibility Female only · 18 Years+
Principal investigator Megahan G Hill, MBBS
Sponsor GE Healthcare (industry)
Started 2017-04-20 → Primary completion 2019-09-20
Primary outcome
FHR Percent Agreement
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - HGM System, Monitoring, Perinatal

All 213
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K231964.
ANNE Maternal
K253021 · Sibel Health, Inc. · Feb 2026
Sonicaid Team3
K250777 · Huntleigh Healthcare , Ltd. · Sep 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · Edan Instruments, Inc. · Aug 2025
Sonicaid Team3
K241368 · Huntleigh Healthcare , Ltd. · Feb 2025
PeriCALM Patterns 3.0
K241009 · Perigen, Inc. · Jan 2025
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
K233440 · Philips Medizin Systeme Boeblingen GmbH · Jul 2024