FDA product code NPB: System, Monitoring, For Progress Of Labor
NPB is the FDA product code for system, monitoring, for progress of labor. It is a Class II device, regulated under 21 CFR 884.2800 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 3 510(k) submissions under NPB, from 2 different applicants. The average 510(k) review took 157 days (median 120). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Monitoring, For Progress Of Labor |
| Device class | Class II |
| Regulation | 21 CFR 884.2800 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NPB clearance
Top NPB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Barnev, Ltd. | 2 | 2009-01-09 |
| Trig Medical, Ltd. | 1 | 2009-03-04 |
Most recent NPB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081984 | Trig Medical, Ltd. | LABORPRO SYSTEM | 2009-03-04 | 236 |
| K082704 | Barnev, Ltd. | BIRTHTRACK (A.K.A. CLM) | 2009-01-09 | 115 |
| K080672 | Barnev, Ltd. | BIRTHTRACK | 2008-07-08 | 120 |
Recalls for NPB devices
openFDA lists no recalls for product code NPB.
Frequently asked questions
What is FDA product code NPB?
NPB is the FDA product code for system, monitoring, for progress of labor. It is a Class II device, regulated under 21 CFR 884.2800 and reviewed by the Obstetrics and Gynecology panel.
What device class is NPB?
Class II, regulation 21 CFR 884.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPB?
Across 3 cleared submissions the average was 157 days from receipt to decision (median 120).
Which companies have the most NPB clearances?
Barnev, Ltd. (2); Trig Medical, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NPB
- Run a recall and safety report across every NPB manufacturer
- Watch product code NPB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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