Cleared Traditional

K241882 - Fetal & Maternal Monitor (F15A, F15A Air) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241882 · Edan Instruments, Inc. · Obstetrics & Gynecology device

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Aug 2025

Decision

425d

Days

Class 2

Risk

K241882 is an FDA 510(k) clearance for the Fetal & Maternal Monitor (F15A, F15A Air). Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 27, 2025 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number	K241882 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 28, 2024
Decision Date	August 27, 2025
Days to Decision	425 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

265d slower than avg

Panel avg: 160d · This submission: 425d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.