Cleared Traditional

K043598 - FC 1400 FETAL MONITOR

K043598 is an FDA 510(k) clearance for FC 1400 FETAL MONITOR, manufactured by Bionet Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K043598 · Bionet Co., Ltd. · Obstetrics & Gynecology device
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Dec 2005
Decision
352d
Days
Class 2
Risk

K043598 is an FDA 510(k) clearance for the FC 1400 FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Bionet Co., Ltd. (Wonju, Kwangwon-Do, KR). The FDA issued a Cleared decision on December 16, 2005 after a review of 352 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bionet Co., Ltd. devices

FDA 510(k) Submission Details - K043598

510(k) Number K043598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date December 16, 2005
Days to Decision 352 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 160d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 100
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K043598.
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PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · Philips Medizin Systeme Boeblingen GmbH · Dec 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
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CADENCE, MODELS 2001 AND 2002
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MODEL 120 SERIES MATERNAL/FETAL MONITOR
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