# K971946: NPB-190 Pulse Oximeter (NPB-190)

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Aug 25, 1997 after 90 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915699 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963707: Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40), Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.
- K962156: 3304 Pulse Oximeter, Bci Intl., Inc. (1996) Summary page 1.

## Most influential descendants
- K052544: Pulse Oximeter Adapter Cables (2006), 0 descendants of its own

## Indications for use
The intended use of the NPB-190 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate. For use with neonatal, pediatric and adult patients, in hospital, hospital-type, intra-hospital transport and home environments. For prescription use only.

Source page: https://510kreport.com/device/K971946
Methodology: https://510kreport.com/methodology