# K982641: Advanced Nibp Module

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Mar 29, 1999 after 243 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896030 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955113: Dinamap Select Multi-Parameter System, Johnson & Johnson Medical, Inc. (1996) Summary page 2.
- K971569: Dinamap MPS Portable Monitor, Johnson & Johnson Medical, Inc. (1997) Summary page 2.

## Indications for use
The Advanced NIBP Module is designed for use with the DINAMAP MPS™ Select™ Family of Monitors, including the DINAMAP MPS Select Portable Monitor and the DINAMAP MPS Select Multiparameter System. The Advanced NIBP Module is intended to obtain a single patient’s systolic, diastolic and mean arterial blood pressures and pulse rate in the same intended use environment as the DINAMAP MPS Select Family of Monitors: hospital, outpatient surgery and healthcare practitioner facilities. The Advanced NIBP Module optimizes performance in the presence of artifact. The Module combines Advanced NIBP for use with small adult, adult, large adult and thigh cuffs with standard NIBP for use with neonatal cuffs. The device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K982641
Methodology: https://510kreport.com/methodology