510(k) · Cleared

Recalled · Class II · 2016

Model 8500 Hand Held Pulse Oximeter

K893221510(k) TraditionalCleared Feb 28, 1990307-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 28, 1990 after a 307-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 432 devices in its family, counting itself, has a Class I recall. 431 later devices descend from it. It has been recalled once.

Decided: Feb 28, 1990
Review: 307 days
Class: Class II
Product code: DQA
Recalls: 1
Predicates: 0

431 later devices descend from it, 4 citing it directly. 1 of the 432 devices in this family, counting this one, has a Class I recall.

This deviceK893221 Model 8500 Hand Held Pulse OximeterNonin Medical, Inc. · 1990
Descendant · cites it directly · 426 of its ownK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
Descendant · cites it directly · 425 of its ownK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
Descendant · 2 generations on · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
Descendant · 3 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
Descendant · 4 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled

Showing 5 of 431 descendants. See all descendants

Descendants cleared per year

1998high 31 (2025) · low 0 (2000)2026

Class I recalls in this family

K123690 CAPNOSTREAM20P with Hifi C02 Monitoring10 generations on · 2014

Most influential descendants

Showing 5 of 431 · See all

K980879Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998 · cites it directly426descendants
K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998 · cites it directly425descendants
K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · 2 generations on272descendants
K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 3 generations on264descendants
K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 4 generations on250descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K893221	Model 8500 Hand Held Pulse Oximeter	Nonin Medical, Inc.	1990	—
+1	K980879	Oscillomate Nibp / SP02 Ems Monitor	Cas Medical Systems, Inc.	1998	—
+1	K982776	9303 Neonatal/Adult Vital Signs Monitor	Cas Medical Systems, Inc.	1998	—
+2	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	1
+3	K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…	Cas Medical Systems, Inc.	2005	—
+4	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0
1999	1	0
2002	2	0
2003	1	0
2004	6	0
2005	5	0
2006	6	0
2007	6	0
2008	7	0
2009	14	0
2010	12	0
2011	15	0
2012	26	0
2013	29	0
2014	24	1
2015	19	0
2016	19	0
2017	23	0
2018	23	0
2019	25	0
2020	25	0
2021	14	0
2022	29	0
2023	23	0
2024	25	0
2025	31	0
2026	18	0

FIG. 1 — Lineage of K893221, 1990–2026Source: 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.

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?

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

What descends from it? (431)

See all 431

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

Number	Device	Applicant	Decided	Descendants
K980879	Oscillomate Nibp / SP02 Ems Monitor	Cas Medical Systems, Inc.	1998	426
K982776	9303 Neonatal/Adult Vital Signs Monitor	Cas Medical Systems, Inc.	1998	425
K980299	Apex Oximeter	Marquette Medical Systems, Inc.	1998	2
K982969	Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847	Nonin Medical, Inc.	1999	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 29, 2016	Class II	Z-1690-2017	Process control	Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated…

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.

K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 10 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K980879 (Cas Medical Systems, Inc., 1998) has gone furthest, with 426 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/K893221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K893221: Model 8500 Hand Held 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/K893221

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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