510(k) · Cleared

Cleared

Model 9600, Avant Pulse Oximeter

K023044510(k) TraditionalCleared Jul 23, 2003314-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

Cleared on Jul 23, 2003 after a 314-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided: Jul 23, 2003
Review: 314 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

6 later devices descend from it, 3 citing it directly.

This deviceK023044 Model 9600, Avant Pulse OximeterNonin Medical, Inc. · 2003
Descendant · cites it directly · 2 of its ownK093853 Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc. · 2010
Descendant · cites it directly · 1 of its ownK124049 Deepview Digital Video Physiological Portable Imaging SystemSpectralmd, Inc. · 2013
Descendant · 2 generations on · 0 of its ownK163339 Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK103685 Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN…Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · 2011
Descendant · 2 generations on · 0 of its ownK103584 Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda…Shenzhen Envisen Industry Co. Limited · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all

K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc. · 2010 · cites it directly2descendants
K124049Deepview Digital Video Physiological Portable Imaging SystemSpectralmd, Inc. · 2013 · cites it directly1descendant
K163339Spectralmd Deepview Wound Imaging System 2.0Spectralmd, Inc. · 2017 · 2 generations on0descendants
K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · 2011 · 2 generations on0descendants
K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023044	Model 9600, Avant Pulse Oximeter	Nonin Medical, Inc.	2003	—
+1	K093853	Single-Patient Use Disposable Sensor Series	Nonin Medical, Inc.	2010	—
+1	K124049	Deepview Digital Video Physiological Portable Imaging System	Spectralmd, Inc.	2013	—
+2	K163339	Spectralmd Deepview Wound Imaging System 2.0	Spectralmd, Inc.	2017	—
+2	K103685	Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA…	Beijing Rongrui-Century Scie. & Tech. Co., Ltd.	2011	—
+2	K103584	Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible…	Shenzhen Envisen Industry Co. Limited	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	2	0
2013	1	0
2017	1	0

FIG. 1 — Lineage of K023044, 2003–2017Source: 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

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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
*	—	Nonin Model Avant 7120 Pulse Oximeter Non Invasive Blood Pressure (NIBP) Monitor Named without a submission number			—

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K093853	Single-Patient Use Disposable Sensor Series	Nonin Medical, Inc.	2010	2
K124049	Deepview Digital Video Physiological Portable Imaging System	Spectralmd, Inc.	2013	1
K093306	Single-Patient Use Disposable Sensor	Nonin Medical, Inc.	2010	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?

Of its descendants, K093853 (Nonin Medical, Inc., 2010) has gone furthest, with 2 descendants of its own.

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?

The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 is intended for continuous monitoring and/or spot-checking of patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023044: Model 9600, Avant Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023044

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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