NPBClass II

System, Monitoring, For Progress Of Labor

21 CFR 884.2800 / Ophthalmic

NPB is the FDA product code for System, Monitoring, For Progress Of Labor, a class II device type, regulated under 21 CFR 884.2800. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2009-03-04, and no recalls.

Classification record

Product code: NPB
Device name: System, Monitoring, For Progress Of Labor
FDA 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.
Regulation: 21 CFR 884.2800
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code NPB

By decision year

4 clearances under product code NPB with a decision year between 2007 and 2009, 2009 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NPB by decision year
Year	Clearances
2007	1
2008	1
2009	2

Applicants with the most clearances

Product code NPB

Applicants holding the most 510(k) clearances under product code NPB
Applicant	Clearances
Barnev, Ltd.	3
Trig Medical, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NPB.

Recent clearances

Product code NPB

Recent recalls

Product code NPB

FDA records show no recalls under product code NPB.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)