Cleared Traditional

K040903 - CADENCE, MODELS 2001 AND 2002

K040903 is an FDA 510(k) clearance for CADENCE, manufactured by Edan Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K040903 · Edan Instruments, 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
148d
Days
Class 2
Risk

K040903 is an FDA 510(k) clearance for the CADENCE, MODELS 2001 AND 2002. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on September 2, 2004 after a review of 148 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 - K040903

510(k) Number K040903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2004
Decision Date September 02, 2004
Days to Decision 148 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
13d faster than avg
Panel avg: 161d · This submission: 148d
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 214
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K040903.
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies · Jun 2005
CALM PATTERNS, VERSION 01.00.00
K040788 · Lms Medical Systems , Ltd. · Feb 2005
AIRSTRIP OB
K042082 · Mp4 Solutions, LP · Jan 2005
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
K040819 · American I.V. Products, Inc. · Aug 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
K040903 · CADENCE, MODELS 2001 AND 2002
Download PDF FDA Summary Edan Instruments, Inc.