Cleared Special

K080672 - BIRTHTRACK

K080672 is an FDA 510(k) clearance for BIRTHTRACK, manufactured by Barnev, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code NPB cleared through the Special 510(k) pathway after a 120-day FDA review.

K080672 · Barnev, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
120d
Days
Class 2
Risk

K080672 is an FDA 510(k) clearance for the BIRTHTRACK. 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 July 8, 2008 after a review of 120 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080672

510(k) Number K080672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date July 08, 2008
Days to Decision 120 days
Submission Type Special
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
41d faster than avg
Panel avg: 161d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

NPB Device Classification - Class 2, Special Controls

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.

K080672 · BIRTHTRACK
Download PDF FDA Summary Barnev, Ltd.