Cleared Traditional

K040819 - TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834

K040819 is an FDA 510(k) clearance for TRANSDUCER FOR ULTRASOUND FETAL MONITORING, manufactured by American I.V. Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K040819 · American I.V. Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
139d
Days
Class 2
Risk

K040819 is an FDA 510(k) clearance for the TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by American I.V. Products, Inc. (Hanover, US). The FDA issued a Cleared decision on August 16, 2004 after a review of 139 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K040819

510(k) Number K040819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2004
Decision Date August 16, 2004
Days to Decision 139 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
22d faster than avg
Panel avg: 161d · This submission: 139d
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 183
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K040819.
CALM PATTERNS, VERSION 01.00.00
K040788 · Lms Medical Systems , Ltd. · Feb 2005
AIRSTRIP OB
K042082 · Mp4 Solutions, LP · Jan 2005
CADENCE, MODELS 2001 AND 2002
K040903 · Edan Instruments, Inc. · Sep 2004
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
K032772 · Hill-Rom Manufacturing, Inc. · Oct 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · Ge Medical Systems Information Technologies · Aug 2003
BATTERY, RECHARGEABLE
K030261 · Access Battery, Inc. · Apr 2003