510(k) · Cleared

Cleared

Avant Digital Pulse Oximetry System, Model 4000, 4100

K052669510(k) TraditionalCleared Dec 23, 200587-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 Dec 23, 2005 as substantially equivalent to K041156 (Nonin Medical, Inc., 2004) after an 87-day review. Its family tree reaches back 6 generations to 1991. 11 later devices descend from it.

Decided: Dec 23, 2005
Review: 87 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K910772 (1991). 13 ancestors in all, the oldest K893221 (1990). 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
5 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
4 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
3 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
2 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
1 generation backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
This deviceK052669 Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc. · 2005
Descendant · cites it directly · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
Descendant · 2 generations on · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
Descendant · 2 generations on · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
Descendant · cites it directly · 2 of its ownK162580 Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2017
Descendant · 3 generations on · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2009high 2 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all

K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · cites it directly7descendants
K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · 2 generations on3descendants
K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · 2 generations on2descendants
K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2017 · cites it directly2descendants
K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K910772	Propaq 102, 104 and 106	Protocol Systems, Inc.	1991	—
−5	K972020	Oscillomate Non-Invasive Blood Pressure Monitor	Cas Medical Systems, Inc.	1998	—
−4	K980879	Oscillomate Nibp / SP02 Ems Monitor	Cas Medical Systems, Inc.	1998	—
−3	K982776	9303 Neonatal/Adult Vital Signs Monitor	Cas Medical Systems, Inc.	1998	—
−2	K013319	Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor	Nonin Medical, Inc.	2002	—
−1	K041156	Avant Digital Pulse Oximetry System, Models 4000, 4001	Nonin Medical, Inc.	2004	1
0 (this device)	K052669	Avant Digital Pulse Oximetry System, Model 4000, 4100	Nonin Medical, Inc.	2005	—
+1	K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	—
+2	K132402	Sensmart Model X-100 Univeral Oximetry System	Nonin Medical, Inc.	2014	1
+2	K172586	Vios Monitoring System™ Model 2050	Vios Medical, Inc.	2018	4
+1	K162580	Guardian Angel GA1000 Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	2017	—
+3	K160865	Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors…	Nonin Medical, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
1993	1	0
1995	1	0
1997	2	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0
2016	1	0
2017	1	0
2018	1	0
2020	2	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K052669, 1991–2025Source: 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
*	K041156	Avant Digital Pulse Oximetry System, Models 4000, 4001 Summary page 1 …the Avant® Model 4000 Pulse Oximetry System manufactured by Nonin Medical, Inc. that was cleared by the FDA under K041156 on 06/09/04. Device Description: The Avant Model 4000 Digital Pulse Oximetry System is a wirele…	Nonin Medical, Inc.	2004	1

Also cleared against K041156: 2 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	7
K162580	Guardian Angel GA1000 Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	2017	2

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?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
2 of the 13 ancestors have a recall of any class.
Of its descendants, K092101 (Nonin Medical, Inc., 2009) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K041156.

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® Model 4000 Digital Pulse Oximetry System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and no motion conditions, and for patients who are well or poorly perfused.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052669 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052669: Avant Digital Pulse Oximetry System, Model 4000, 4100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052669

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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