Cleared Traditional

K112187 - FM-1000 PLUS FETAL MONITOR

K112187 is an FDA 510(k) clearance for FM-1000 PLUS FETAL MONITOR, manufactured by Advanced Instrumentations, Inc.. The device is a Class 2 Radiology device with product code HGM cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K112187 · Advanced Instrumentations, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
54d
Days
Class 2
Risk

K112187 is an FDA 510(k) clearance for the FM-1000 PLUS FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Advanced Instrumentations, Inc. (Hialeah, US). The FDA issued a Cleared decision on September 21, 2011 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2740 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K112187

510(k) Number K112187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date September 21, 2011
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
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 Radiology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 189
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K112187.
FM20
K110612 · Mediana Co., Ltd. · Nov 2011
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K112159 · Advanced Instrumentations, Inc. · Sep 2011
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K111083 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2011
MINI TELEMETRY SYSTEM
K110556 · Wipro GE Healthcare Private, Ltd. · Jul 2011
BT-350
K103545 · Bistos Co., Ltd. · May 2011
K112187 · FM-1000 PLUS FETAL MONITOR
Download PDF FDA Summary Advanced Instrumentat…