510(k) · Cleared

Cleared

Masimo Set/Quartz 2500 Pulse Oximeter and Accessories

K993555510(k) SpecialCleared Nov 19, 199930-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 19, 1999 after a 30-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided: Nov 19, 1999
Review: 30 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK993555 Masimo Set/Quartz 2500 Pulse Oximeter and AccessoriesMasimo Corp. · 1999
Descendant · cites it directly · 0 of its ownK050018 Teslaoxysat, Model EfoxysateMammendorfer Institute For Physics & Medicine GmbH · 2005

Most influential descendants

Showing 1 of 1 · See all

K050018Teslaoxysat, Model EfoxysateMammendorfer Institute For Physics & Medicine GmbH · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K993555	Masimo Set/Quartz 2500 Pulse Oximeter and Accessories	Masimo Corp.	1999	—
+1	K050018	Teslaoxysat, Model Efoxysate	Mammendorfer Institute For Physics & Medicine GmbH	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K993555, 1999–2005Source: 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
*	—	Masimo SET® 2000 Pulse Oximeter and Accessories Named without a submission number			—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050018	Teslaoxysat, Model Efoxysate	Mammendorfer Institute For Physics & Medicine GmbH	2005	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, K050018 (Mammendorfer Institute For Physics & Medicine GmbH, 2005) has gone furthest, with 0 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 Masimo SET*/Quartz 2500 Pulse Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation or arterial hemoglobin (SpO,) and pulse rate (measured by an SpO, sensor). The Masimo SET®/Quartz 2500 Pulse Oximeter and accessories are 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…

Read the full statement (191 words)

The Masimo LNOP® Series of Sensors are indicated for the Masimo SET®/Quartz 2500 Pulse Oximeter and the following:

A single use oximetry sensor intended for adults and pediatrics greater than 30kg.

A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg;

A single use oximetry sensor intended for neconates with good skin integrity Jess than 10kg;

A single use oximetry sensor intended for neonates with poor skin integrity less than 1kg; and

a reusable oximetry sensor intended for aduits apd pediatrics greater than 30kg.

The Masimo PC Sedes of Patient Cables are indicated for use with the Masitno LNOP® Series of Sensors and the Masimo SET®/Quartz 2500 Pulse Oximeter.

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/K993555 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993555: Masimo Set/Quartz 2500 Pulse Oximeter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993555

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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