510(k) · Cleared

Cleared

OSM3 Hemoximeter

K853990510(k) TraditionalCleared Dec 30, 198594-day reviewClass I21 CFR 862.3220

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

Radiometer America, Inc. · JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

Cleared on Dec 30, 1985 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 247 devices in its family, counting itself, have a Class I recall. 246 later devices descend from it.

Decided: Dec 30, 1985
Review: 94 days
Class: Class I
Product code: JKS
Recalls: None
Predicates: 0

246 later devices descend from it, 4 citing it directly. 2 of the 247 devices in this family, counting this one, have a Class I recall.

This deviceK853990 OSM3 HemoximeterRadiometer America, Inc. · 1985
Descendant · cites it directly · 244 of its ownK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
Descendant · cites it directly · 226 of its ownK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
Descendant · 2 generations on · 225 of its ownK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
Descendant · cites it directly · 219 of its ownK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
Descendant · 2 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009

Showing 5 of 246 descendants. See all descendants

Descendants cleared per year

2005high 24 (2023) · low 1 (2007)2026

Class I recalls in this family

K123690 CAPNOSTREAM20P with Hifi C02 Monitoring4 generations on · 2014
K160552 EV1000 Clinical Platform with ClearSight Finger…5 generations on · 2016

Most influential descendants

Showing 5 of 246 · 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 · cites it directly226descendants
K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006 · 2 generations on225descendants
K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation · 2008 · cites it directly219descendants
K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 2 generations on155descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K853990	OSM3 Hemoximeter	Radiometer America, Inc.	1985	—
+1	K042536	Masimo Set Rad 57 Pulse CO-Oximeter	Masimo Corporation	2005	1
+1	K053477	Masimo Set Rad 57 CM and M Pulse CO-Oximeters	Masimo Corporation	2006	—
+2	K061204	Masimo Set Radical 7 Pulse CO-Oximeter	Masimo Corporation	2006	—
+1	K080238	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87…	Masimo Corporation	2008	1
+2	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	3	0
2006	4	0
2007	1	0
2008	4	0
2009	3	0
2010	5	0
2011	7	0
2012	6	0
2013	7	0
2014	16	1
2015	8	0
2016	9	1
2017	10	0
2018	14	0
2019	21	0
2020	13	0
2021	15	0
2022	23	0
2023	24	0
2024	20	0
2025	18	0
2026	15	0

FIG. 1 — Lineage of K853990, 1985–2026Source: 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.

2 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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? (246)

See all 246

4 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
K053477	Masimo Set Rad 57 CM and M Pulse CO-Oximeters	Masimo Corporation	2006	226
K080238	Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…	Masimo Corporation	2008	219
K050014	Hemonir TM	Nir Diagnostics, Inc.	2005	0

Has anything in its family been recalled? (2 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.

K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K042536 (Masimo Corporation, 2005) has gone furthest, with 244 descendants of its own.

How does its category compare?

All JKS devices

JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKS

FDA has decided no JKS device since 2007.

Median 510(k) review, days · JKS

Too few JKS 510(k)s in any year since 2007 to give a median.

Recalls per year · JKS

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKS

1in 2018

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code JKS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	1
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K853990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K853990: OSM3 Hemoximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853990

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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