510(k) · Cleared

Cleared

Score Software

K961450510(k) TraditionalCleared Aug 1, 1996108-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nellcor Puritan Bennett, Inc. · DQA Oximeter

Cleared on Aug 1, 1996 as substantially equivalent to K913695 (Nellcor, Inc., 1991) after a 108-day review. Its family tree reaches back 1 generation to 1991. 13 later devices descend from it.

Decided: Aug 1, 1996
Review: 108 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K913695 (1991). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK913695 Nellcor (R) N-180 Pulse OximeterNellcor, Inc. · 1991
This deviceK961450 Score SoftwareNellcor Puritan Bennett, Inc. · 1996
Descendant · cites it directly · 7 of its ownK033307 Nvision Data Management SoftwareNonin Medical, Inc. · 2004
Descendant · 2 generations on · 4 of its ownK092678 Evision Data Management SoftwareNonin Medical, Inc. · 2009
Descendant · 3 generations on · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
Descendant · cites it directly · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
Descendant · 4 generations on · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002high 2 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all

K033307Nvision Data Management SoftwareNonin Medical, Inc. · 2004 · cites it directly7descendants
K092678Evision Data Management SoftwareNonin Medical, Inc. · 2009 · 2 generations on4descendants
K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · 3 generations on3descendants
K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · cites it directly3descendants
K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913695	Nellcor (R) N-180 Pulse Oximeter	Nellcor, Inc.	1991	—
0 (this device)	K961450	Score Software	Nellcor Puritan Bennett, Inc.	1996	—
+1	K033307	Nvision Data Management Software	Nonin Medical, Inc.	2004	—
+2	K092678	Evision Data Management Software	Nonin Medical, Inc.	2009	—
+3	K132402	Sensmart Model X-100 Univeral Oximetry System	Nonin Medical, Inc.	2014	1
+1	K101690	Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor…	Sentec AG	2010	12
+4	K160865	Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors…	Nonin Medical, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2006	1	0
2008	1	0
2009	1	0
2010	1	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2020	1	0
2024	2	0

FIG. 1 — Lineage of K961450, 1991–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K913695	Nellcor (R) N-180 Pulse Oximeter Summary page 1 …iagnose any specific disease. 13.6 Predicate Device Equivalence We are claiming substantial equivalence Nelicor P200S Thermal Printer first described in cleared 510(k) K913695 13.7 Device Description Depending on which pulse oximeter the clinician uses and how the pulse oximeter parameters are set, the…	Nellcor, Inc.	1991	—

Also cleared against K913695: 5 other devices →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033307	Nvision Data Management Software	Nonin Medical, Inc.	2004	7
K101690	Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable	Sentec AG	2010	3
K013862	Bci 1621 Oximetry Data Management Program	Bci, Inc.	2002	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K033307 (Nonin Medical, Inc., 2004) has gone furthest, with 7 descendants of its own.
5 other devices also cite its predicate K913695.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K961450 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961450: Score Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961450

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026