Cleared Traditional

K040392 - TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

K040392 is an FDA 510(k) clearance for TRANSDUCERS FOR ULTRASOUND AND TOCODYNA..., manufactured by American I.V. Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K040392 · 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
Sep 2004
Decision
210d
Days
Class 2
Risk

K040392 is an FDA 510(k) clearance for the TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by American I.V. Products, Inc. (Hanover, US). The FDA issued a Cleared decision on September 14, 2004 after a review of 210 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - 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 - K040392

510(k) Number K040392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date September 14, 2004
Days to Decision 210 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
49d slower than avg
Panel avg: 161d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFM Device Classification - Class 2, Special Controls

Product Code HFM Monitor, Uterine Contraction, External (for Use In Clinic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
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 - HFM Monitor, Uterine Contraction, External (for Use In Clinic)

All 12
Devices cleared under the same product code (HFM) and FDA review panel - the closest regulatory comparables to K040392.
KOALA TOCO
K140163 · Clinical Innovations, LLC · May 2014
FEATHERLITE AQUA TOCODYNAMOMETER
K061044 · Ventrex, Inc. · Jul 2006
TOCO LITE, MODEL TD-01
K013477 · Ventrex, Inc. · Jan 2002
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353 · Precision Dynamics Corp. · Mar 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811 · Epic Medical Equipment Services, Inc. · Jan 2000
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K954847 · Ocg Systems, Inc. · May 1996