Cleared Traditional

K043075 - TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

K043075 is an FDA 510(k) clearance for TENACORE TRANSDUCERS FOR FETAL ULTRASON..., manufactured by Tenacore Holdings, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K043075 · Tenacore Holdings, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
283d
Days
Class 2
Risk

K043075 is an FDA 510(k) clearance for the TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Tenacore Holdings, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 18, 2005 after a review of 283 days - an extended review cycle.

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 - K043075

510(k) Number K043075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date August 18, 2005
Days to Decision 283 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
122d slower than avg
Panel avg: 161d · This submission: 283d
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 K043075.
FC 1400 FETAL MONITOR
K043598 · Bionet Co., Ltd. · Dec 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
K052190 · Bistos Co., Ltd. · Oct 2005
REMOTE CARE
K050234 · E.Care Solutions, Inc. · Aug 2005
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