# K972468: NPB-195 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Sep 25, 1997 after 86 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). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 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.
- K962127: Ohmeda 3800 Pulse Oximeter, Ohmeda Medical (1996) Summary page 1.

## Most influential descendants
- K041548: Sentec Digital Monitor Model #SDM (2004), 5 descendants of its own
- K071672: Sentec Digital Monitoring System (2007), 4 descendants of its own
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), 3 descendants of its own
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), 1 descendant of its own
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (2024), 0 descendants of its own

## Indications for use
The intended use of the NPB-195 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO₂) 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/K972468
Methodology: https://510kreport.com/methodology