510(k) · Cleared

Cleared

Model 8500, Hand Held Pulse Oximeter, Model 8500

K001930510(k) SpecialCleared Jul 20, 200024-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 Jul 20, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 65 later devices descend from it.

Decided: Jul 20, 2000
Review: 24 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

65 later devices descend from it, 3 citing it directly.

This deviceK001930 Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc. · 2000
Descendant · cites it directly · 62 of its ownK050056 Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · Recalled
Descendant · 2 generations on · 29 of its ownK071285 Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007
Descendant · 2 generations on · 22 of its ownK100077 Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model…Solaris Medical Technology, Inc. · 2010
Descendant · 3 generations on · 17 of its ownK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
Descendant · 3 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2004high 10 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 65 · See all

K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · cites it directly62descendants
K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007 · 2 generations on29descendants
K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010 · 2 generations on22descendants
K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010 · 3 generations on17descendants
K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001930	Model 8500, Hand Held Pulse Oximeter, Model 8500	Nonin Medical, Inc.	2000	—
+1	K050056	Model 2500A Palmsat Pulse Oximeter	Nonin Medical, Inc.	2005	1
+2	K071285	Digital Pulse Oximeter, Model 7500	Nonin Medical, Inc.	2007	—
+2	K100077	Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103	Solaris Medical Technology, Inc.	2010	—
+3	K101674	WVSM (Wireless Vital Signs Monitor), Model 5.0	Athena Gtx	2010	—
+3	K142832	Unimed Disposable and Reusable SPO2 Sensors	Unimed Medical Supplies, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2007	3	0
2008	1	0
2009	2	0
2010	4	0
2011	3	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	4	0
2017	2	0
2018	6	0
2019	3	0
2020	7	0
2022	2	0
2023	2	0
2024	4	0
2025	10	0
2026	6	0

FIG. 1 — Lineage of K001930, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (65)

See all 65

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

Number	Device	Applicant	Decided	Descendants
K050056	Model 2500A Palmsat Pulse Oximeter	Nonin Medical, Inc.	2005	62
K061896	Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02…	Mediaid, Inc.	2007	0
K033998	Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V	Masimo Corp.	2004	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, K050056 (Nonin Medical, Inc., 2005) has gone furthest, with 62 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	—

https://510kreport.com/device/K001930 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001930: Model 8500, Hand Held Pulse Oximeter, Model 8500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001930

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026