510(k) Report

510(k) · Cleared

Cleared

Onyx II Finger Pulse Oximeter, Model 9550

K051107510(k) SpecialCleared Jun 1, 200530-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

Nonin Medical, Inc. · DQA Oximeter

Cleared on Jun 1, 2005 as substantially equivalent to K001085 (Nonin Medical, Inc., 2000) after a 30-day review. Its family tree reaches back 1 generation to 2000. 154 later devices descend from it.

Decided
Jun 1, 2005
Review
30 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001085 (2000). 154 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 2 descendants cleared2013: 8 descendants cleared2012: 6 descendants cleared2008: 6 descendants cleared2015: 6 descendants cleared2014: 6 descendants cleared2010: 6 descendants cleared2018: 8 descendants cleared2009: 4 descendants cleared2016: 8 descendants cleared2017: 4 descendants cleared2022: 16 descendants cleared2020: 7 descendants cleared2019: 10 descendants cleared2011: 1 descendant cleared2021: 7 descendants cleared2023: 12 descendants cleared2026: 10 descendants cleared2024: 15 descendants cleared2025: 11 descendants clearedK001085 · Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 · Nonin Medical, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 16 descendants3 generations forward: 27 descendants4 generations forward: 28 descendants5 generations forward: 34 descendants6 generations forward: 29 descendants7 generations forward: 15 descendants8 generations forward: 1 descendant K001085 · Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 · Nonin Medical, Inc. · 20000+5
  1. Root · 1 generation backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
  2. This deviceK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
  3. Descendant · cites it directly · 79 of its ownK070371 Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007
  4. Descendant · cites it directly · 59 of its ownK053130 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2006
  5. Descendant · 2 generations on · 40 of its ownK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
  6. Descendant · 2 generations on · 27 of its ownK112843 Pulse OximeterNonin Medical, Inc. · 2012
  7. Descendant · 3 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015

Showing 5 of 154 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 62009: 42010: 62011: 12012: 62013: 82014: 62015: 62016: 82017: 42018: 82019: 102020: 72021: 72022: 162023: 122024: 152025: 112026: 10
2006high 16 (2022) · low 1 (2006)2026

Most influential descendants

Showing 5 of 154 · See all
  • K070371Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd. · 2007 · cites it directly79descendants
  • K053130Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2006 · cites it directly59descendants
  • K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008 · 2 generations on40descendants
  • K112843Pulse OximeterNonin Medical, Inc. · 2012 · 2 generations on27descendants
  • K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001085Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc.2000—
0 (this device)K051107Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc.2005—
+1K070371Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd.2007—
+1K053130Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc.2006—
+2K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.2008—
+2K112843Pulse OximeterNonin Medical, Inc.2012—
+3K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200860
200940
201060
201110
201260
201380
201460
201560
201680
201740
201880
2019100
202070
202170
2022160
2023120
2024150
2025110
2026100
FIG. 1 — Lineage of K051107, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K001085Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500
Summary page 1
….2700 Product Code: 74 DQA Predicate Device(s): The predicate device is the Model 9500 Onyx® Finger Pulse Oximeter, K001085, cleared on May 1, 2000. Device Description: The Model 9550 Onyx® II is a small, lightweight,…
Nonin Medical, Inc.2000—

Also cleared against K001085: 3 other devices →

What descends from it? (154)

See all 154

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

NumberDeviceApplicantDecidedDescendants
K070371Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd.200779
K053130Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc.200659
K130947Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.201310
K063641PC-60, Non-Invasivepulse OximeterShenzhen Creative Industry Co., Ltd.20072

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?

  • Its one ancestor has no recall.
  • Of its descendants, K070371 (Beijing Choice Electronic Technololgy Co., Ltd., 2007) has gone furthest, with 79 descendants of its own.
  • 3 other devices also cite its predicate K001085.

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

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
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

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.

Indications for use as stated in the FDA summary.

Also cleared against K001085

3 other devices cite the same predicate.

  • K113865PultolSharp Corporation · 2012
  • K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
  • K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002

More from Nonin Medical, Inc.

50 FDA decisions under this applicant name. See the company

  • K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024
  • K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
  • K191403Pulse OximeterNonin Medical, Inc. · 2019
  • K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InterfaceNonin Medical, Inc. · 2019
  • K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc. · 2018

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K051107 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051107: Onyx II Finger Pulse Oximeter, Model 9550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051107

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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