510(k) · Cleared

Cleared

Single-Patient Use Disposable Sensor

K093306510(k) SpecialCleared Mar 4, 2010133-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 Mar 4, 2010 as substantially equivalent to K063752 (Nonin Medical, Inc., 2007) and 3 other predicates after a 133-day review. Its family tree reaches back 4 generations to 1995. 1 of the 10 devices in its family, counting itself, has a Class I recall.

Decided: Mar 4, 2010
Review: 133 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K950387 (1995). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK950387 GeminiSpegas Industries, Ltd. · 1995
3 generations backK964239 Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
2 generations backK024300 Microcap Plus/NPB-75Oridion Medical 1987, Ltd. · 2003
1 generation backK063752 Lifesense, Model LS1-9RNonin Medical, Inc. · 2007
This deviceK093306 Single-Patient Use Disposable SensorNonin Medical, Inc. · 2010

Class I recalls in this family

K970209 Capnocheck Plus2 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K950387	Gemini	Spegas Industries, Ltd.	1995	—
−3	K964239	Combination Oximeter/Carbon Dioxide Gas Analyzer	Spegas Industries, Ltd.	1997	—
−2	K024300	Microcap Plus/NPB-75	Oridion Medical 1987, Ltd.	2003	—
−1	K063752	Lifesense, Model LS1-9R	Nonin Medical, Inc.	2007	—
0 (this device)	K093306	Single-Patient Use Disposable Sensor	Nonin Medical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	1
2000	2	0
2003	1	0
2005	1	0

FIG. 1 — Lineage of K093306, 1995–2010Source: 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.

1 device in this family has 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

Get a 510(k) Report

What was it cleared against? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K071280	FDA’s K071280 is Synchron CX Delta Clinical Systems, Creatinine Test Systems Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Beckman Coulter, Inc.	2007	—
*	K063752	Lifesense, Model LS1-9R Summary page 1 …ensor as cleared in the following 510(K) submissions: Model 7500 (K07128 cleared on July 12, 2007), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K(050056…	Nonin Medical, Inc.	2007	—
*	K023044	Model 9600, Avant Pulse Oximeter Summary page 1 …issions: Model 7500 (K07128 cleared on July 12, 2007), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K(050056 cleared on June 21, 2005), and Model 2500 (K(002690 clear…	Nonin Medical, Inc.	2003	—
*	K050056	Model 2500A Palmsat Pulse Oximeter Summary page 1 …07), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K(050056 cleared on June 21, 2005), and Model 2500 (K(002690 cleared on October 11, 2000).…	Nonin Medical, Inc.	2005	1
*	K002690	Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 Summary page 1 …4, 2007), Model 9600 (K023044 cleared on July 23, 2003), Model 2500A (K(050056 cleared on June 21, 2005), and Model 2500 (K(002690 cleared on October 11, 2000). Device Description: The 6500MA (wrap-around model) and 6500SA (interlock…	Nonin Medical, Inc.	2000	2

Also cleared against K063752: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

K970209Capnocheck PlusBci Intl., Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
2 other devices also cite its predicate K063752.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093306: Single-Patient Use Disposable Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093306

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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