# K961450: Score Software

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Aug 1, 1996 after 108 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 K913695 (1991). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913695: Nellcor (R) N-180 Pulse Oximeter, Nellcor, Inc. (1991) Summary page 1.

## Most influential descendants
- K033307: Nvision Data Management Software (2004), 7 descendants of its own
- K092678: Evision Data Management Software (2009), 4 descendants of its own
- K132402: Sensmart Model X-100 Univeral Oximetry System (2014), 3 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
- K160865: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso (2016), 1 descendant of its own

## Indications for use
Score Software is an accessory to two NPB pulse oximeters. It is intended to provide clinicians with the ability to collect, edit, and analyze trend data recorded by a Nellcor Symphony™ N-3000 pulse oximeter or a Nellcor Puritan Bennett™ N-200 pulse oximeter. It provides general functions that are not intended to diagnose any specific disease.

Source page: https://510kreport.com/device/K961450
Methodology: https://510kreport.com/methodology