510(k) · Cleared

Cleared

Wristox Model 3100 Pulse Oximeter

K052829510(k) TraditionalCleared Nov 10, 200536-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 Nov 10, 2005 as substantially equivalent to K030668 (Nonin Medical, Inc., 2003) after a 36-day review. Its family tree reaches back 2 generations to 2000.

Decided: Nov 10, 2005
Review: 36 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K002690 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002690 Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Nonin Medical, Inc. · 2000 · Recalled
1 generation backK030668 Model 3100 Wristox Pulse OximeterNonin Medical, Inc. · 2003
This deviceK052829 Wristox Model 3100 Pulse OximeterNonin Medical, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002690	Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500	Nonin Medical, Inc.	2000	2
−1	K030668	Model 3100 Wristox Pulse Oximeter	Nonin Medical, Inc.	2003	—
0 (this device)	K052829	Wristox Model 3100 Pulse Oximeter	Nonin Medical, Inc.	2005	—

FIG. 1 — Lineage of K052829, 2000–2005Source: 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
*	K030668	Model 3100 Wristox Pulse Oximeter Summary page 1 …21 CFR 870.2700 Product Code: 74 DQA Predicate Device(s): Model 3100 WristOx® is substantially equivalent to the Model 3100 WristOx® (K030668), which is also manufactured by Nonin Medical. Device Description: The Nonin Model 3100 WristOx® is a…	Nonin Medical, Inc.	2003	—

Also cleared against K030668: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K030668.

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® Model 3100 WristOx® Pulse Oximeter is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052829 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052829: Wristox Model 3100 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/K052829

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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