# K963707: Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Dec 13, 1996 after 88 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: 1 generation back to K915699 (1993). 1 ancestor in all.
58 later devices descend from it; 5 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915699: Nellcor Portable Pulse Oximeter Model N-20, Nellcor, Inc. (1993) Summary page 1.

## Most influential descendants
- K051352: Oximax NPB-40 Handheld Pulse Oximeter (2005), 28 descendants of its own
- K072581: PM-60 Pulse Oximeter (2008), 19 descendants of its own
- K070193: Envitec Oxipen Pulse Oximeter and Accessories (2007), 15 descendants of its own
- K113165: Mini-Medic (2012), 13 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own

## Indications for use
The NPB-40 Handheld Pulse Oximeter is intended for non-invasive spot-check measurement of functional arterial oxygen saturation (Sp02) and pulse rate of adults, pediatric, and neonatal patients in hospital, emergency, transport, and mobile environments, as well as in the home. The NPB-40 is for attended monitoring only and is intended to be used under the direct observation of a qualified health care provider.

Source page: https://510kreport.com/device/K963707
Methodology: https://510kreport.com/methodology