# K051352: Oximax NPB-40 Handheld Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Aug 11, 2005 after 79 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: 6 generations back to K962603 (1997). 12 ancestors in all.
28 later devices descend from it; 5 cite it directly.
0 of 41 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.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K072581: PM-60 Pulse Oximeter (2008), 19 descendants of its own
- K090599: MD300K1 Pulse Oximeter (2009), 9 descendants of its own
- K152563: Pulse Oximeter (MD300M/MD300K2) (2016), 8 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own

## Indications for use
The OxiMaxTM NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities, transport and mobile environments as well as in the home care environment.

Source page: https://510kreport.com/device/K051352
Methodology: https://510kreport.com/methodology