DeviceClearance

Product code NPB— Ophthalmic

BIRTHTRACK

Classification name
System, Monitoring, For Progress Of Labor
Device class
Class 2
Regulation
21 CFR 884.2800
Advisory panel
Ophthalmic
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NPB under 21 CFR 884.2800, via openFDA

Market context for product code NPB

FDA has cleared 4 devices under product code NPB between 2007 and 2009, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NPB

Recent clearances under product code NPB

Data sourced from openFDA. This site is unofficial and independent of the FDA.