# K973147: NPB-295 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Nov 14, 1997 after 84 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852316 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942347: Nellcor Symphony Pulse Oximeter Model N-3000, Nellcor, Inc. (1995) Summary page 1.
- K852316: #3011 Pediatric Non-Conduct Anes Cir W/ Brea Bag, Sigma Medical, Inc. (1985) Summary page 1.

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

## Recalls of this device
- Oct 18, 2004 · Not classified · Z-0663-05: The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

## Indications for use
The intended use of the NPB-295 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/K973147
Methodology: https://510kreport.com/methodology