# K980411: NPB3900 Series Patient Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: Aug 20, 1998 after 198 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943695 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962424: NPB-4000, Analogic Corp. (1996) Summary page 1.
- K943695: Suretemp, Advanced Bioresearch Assoc. (1995) Summary page 1.
- K964643: Suretemp, Diatek Instruments, Inc. (1997) Summary page 1.

## Most influential descendants
- K041376: C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer for CI, Model M3925A (2004), 0 descendants of its own

## Indications for use
The NPB3900 Series Patient Monitors are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure, (systolic, diastolic, and mean arterial pressure), functional arterial oxygen saturation, and temperature for adult and pediatric patients in all hospital areas and hospital type facilities and for patient transport in the hospital and in ambulances.

Source page: https://510kreport.com/device/K980411
Methodology: https://510kreport.com/methodology