510(k) · Cleared

Recalled · Class II · 2023

Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V

K033296510(k) TraditionalCleared Feb 19, 2004128-day reviewClass II21 CFR 870.2700Recalls 1

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

Cleared on Feb 19, 2004 as substantially equivalent to K031330 (Masimo Corp., 2003) after a 128-day review. Its family tree reaches back 2 generations to 2000. 5 of the 282 devices in its family, counting itself, have a Class I recall. 279 later devices descend from it. It has been recalled once.

Decided: Feb 19, 2004
Review: 128 days
Class: Class II
Product code: DQA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K000126 (2000). 279 later devices descend from it, 11 citing it directly. 5 of the 282 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
1 generation backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
This deviceK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004
Descendant · cites it directly · 244 of its ownK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
Descendant · 2 generations on · 226 of its ownK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
Descendant · 3 generations on · 225 of its ownK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
Descendant · 3 generations on · 219 of its ownK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
Descendant · 4 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009

Showing 5 of 279 descendants. See all descendants

Descendants cleared per year

2005high 24 (2023) · low 1 (2007)2026

Class I recalls in this family

K111473 Uni-Vent (R) Model 731 Series Portable Critical…4 generations on · 2012
K162832 731 Series Ventilators5 generations on · 2017
K123690 CAPNOSTREAM20P with Hifi C02 Monitoring6 generations on · 2014
K153046 Hamilton-MR16 generations on · 2016

Most influential descendants

Showing 5 of 279 · See all

K042536Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · cites it directly244descendants
K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006 · 2 generations on226descendants
K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006 · 3 generations on225descendants
K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation · 2008 · 3 generations on219descendants
K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 4 generations on155descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000126	Masimo Set Radical Pulse Oximeter with Satshare, Masimo…	Masimo Corp.	2000	—
−1	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2003	—
0 (this device)	K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse…	Masimo Corp.	2004	—
+1	K042536	Masimo Set Rad 57 Pulse CO-Oximeter	Masimo Corporation	2005	1
+2	K053477	Masimo Set Rad 57 CM and M Pulse CO-Oximeters	Masimo Corporation	2006	—
+3	K061204	Masimo Set Radical 7 Pulse CO-Oximeter	Masimo Corporation	2006	—
+3	K080238	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87…	Masimo Corporation	2008	1
+4	K091241	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter	Masimo Corporation	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	5	0
2007	1	0
2008	10	0
2009	8	0
2010	7	0
2011	10	0
2012	7	1
2013	10	0
2014	17	1
2015	11	0
2016	11	2
2017	13	1
2018	14	0
2019	22	0
2020	13	0
2021	15	0
2022	23	0
2023	24	0
2024	21	0
2025	18	0
2026	15	0

FIG. 1 — Lineage of K033296, 2000–2026Source: 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.

5 devices in this family have a Class I recall. 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
*	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of… Summary page 1 …meter with SatShareTm and LNOP series of Sensors and Cables 5 10O(k) Number - K03 1330 Features and Benefits Clinically proven Masimo SET TMtechnology performnance Applicable for use on neonate, pe…	Masimo Corp.	2003	—

Also cleared against K031330: 13 other devices →

What descends from it? (279)

See all 279

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

Number	Device	Applicant	Decided	Descendants
K042536	Masimo Set Rad 57 Pulse CO-Oximeter	Masimo Corporation	2005	244
K053269	Masimo Set Rad-8 Pulse Oximeter	Masimo Corporation	2005	83
K120657	Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors	Masimo Corporation	2012	37
K061329	Infinity Masimo Set SP02 Pod	Draeger Medical Systems, Inc.	2006	25
K090556	Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software	Spacelabs Healthcare Medical Equipment (Suzhou) CO	2009	10
K071526	Uni-Vent 731 Series Ventilators, Model 731, 731EMV	Impact Instrumentation, Inc.	2008	7
K070985	Aesculon CHF, Hypertension & Pacemaker Clinic	Osypka Medical, Inc.	2008	4
K100225	Pulse Oximeter Model P10	Mediana Co., Ltd.	2011	3
K081891	Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor	Fukuda Denshi USA, Inc.	2008	3
K050605	Spacelabs Medical Multiparameter Module 91496	Spacelabs Medical, Inc.	2005	1

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 21, 2023	Class II	Z-1984-2023	Nonconforming Material/Component	TC-I tip clip sensor may produce readings outside the accuracy specification.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K153046Hamilton-MR1Hamilton Medical AG · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K042536 (Masimo Corporation, 2005) has gone furthest, with 244 descendants of its own.
13 other devices also cite its predicate K031330.

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 Masimo SET® Rad5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033296 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033296

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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