Cleared Traditional

K082704 - BIRTHTRACK (A.K.A. CLM) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082704 · Barnev, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
115d
Days
Class 2
Risk

K082704 is an FDA 510(k) clearance for the BIRTHTRACK (A.K.A. CLM). Classified as System, Monitoring, For Progress Of Labor (product code NPB), Class II - Special Controls.

Submitted by Barnev, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on January 9, 2009 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2800 - 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.

View all Barnev, Ltd. devices

Submission Details

510(k) Number K082704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date January 09, 2009
Days to Decision 115 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
45d faster than avg
Panel avg: 160d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPB System, Monitoring, For Progress Of Labor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2800
Definition This Monitoring System For Progress Of Labor Provides Intrapartum Measurement Of Cervical Dilation, Fetal Head Station, And/or Other Sentinel Anatomical Markers. This Device Is Intended To Be Used Adjunctively With Other Diagnostic Information In Order To Clinically Follow The Progress Of Labor.
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.