Cleared Traditional

K050826 - FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS

K050826 is an FDA 510(k) clearance for FETAL ULTRASOUND AND TOCODYNAMOMETER TR..., manufactured by Cetro America. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K050826 · Cetro America · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
374d
Days
Class 2
Risk

K050826 is an FDA 510(k) clearance for the FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Cetro America (Hamden, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 374 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 Cetro America devices

FDA 510(k) Submission Details - K050826

510(k) Number K050826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date April 10, 2006
Days to Decision 374 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
214d slower than avg
Panel avg: 160d · This submission: 374d
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 137
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K050826.
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · Ge Healthcare · Dec 2007
PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K071800 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Sep 2007
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K062137 · Philips Medizin Systeme Boeblingen GmbH · Aug 2006
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · Philips Medizin Systeme Boeblingen GmbH · Dec 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies · Jun 2005
CADENCE, MODELS 2001 AND 2002
K040903 · Edan Instruments, Inc. · Sep 2004