510(k) · Cleared

Cleared

Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500

K001085510(k) SpecialCleared May 1, 200027-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 May 1, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 197 later devices descend from it.

Decided: May 1, 2000
Review: 27 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

197 later devices descend from it, 4 citing it directly.

This deviceK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
Descendant · cites it directly · 154 of its ownK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
Descendant · 2 generations on · 79 of its ownK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
Descendant · 2 generations on · 59 of its ownK053130 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2006
Descendant · cites it directly · 43 of its ownK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
Descendant · 2 generations on · 42 of its ownK043528 SpirotelMir Medical Intl. Research Srl · 2005

Showing 5 of 197 descendants. See all descendants

Descendants cleared per year

2002high 20 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 197 · See all

K051107Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005 · cites it directly154descendants
K070371Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007 · 2 generations on79descendants
K053130Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2006 · 2 generations on59descendants
K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002 · cites it directly43descendants
K043528SpirotelMir Medical Intl. Research Srl · 2005 · 2 generations on42descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001085	Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500	Nonin Medical, Inc.	2000	—
+1	K051107	Onyx II Finger Pulse Oximeter, Model 9550	Nonin Medical, Inc.	2005	—
+2	K070371	Fingertip Pulse Oximeter MD300C	Beijing Choice Electronic Technololgy Co., Ltd.	2007	—
+2	K053130	Onyx II Finger Pulse Oximeter, Model 9550	Nonin Medical, Inc.	2006	—
+1	K013171	3420 Digit Pulse Oximeter, Model 3420	Bci, Inc.	2002	—
+2	K043528	Spirotel	Mir Medical Intl. Research Srl	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	2	0
2006	2	0
2007	3	0
2008	7	0
2009	6	0
2010	6	0
2011	3	0
2012	6	0
2013	9	0
2014	7	0
2015	7	0
2016	8	0
2017	7	0
2018	9	0
2019	11	0
2020	13	0
2021	9	0
2022	18	0
2023	18	0
2024	20	0
2025	13	0
2026	11	0

FIG. 1 — Lineage of K001085, 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? (197)

See all 197

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

Number	Device	Applicant	Decided	Descendants
K051107	Onyx II Finger Pulse Oximeter, Model 9550	Nonin Medical, Inc.	2005	154
K013171	3420 Digit Pulse Oximeter, Model 3420	Bci, Inc.	2002	43
K040178	Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device	S.P.O. Medical Equipment, Ltd.	2004	5
K113865	Pultol	Sharp Corporation	2012	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, K051107 (Nonin Medical, Inc., 2005) has gone furthest, with 154 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/K001085 · printed Nov 3, 2026

Cite this page

510(k) Report. “K001085: Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001085

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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