510(k) Report

510(k) · Cleared

Cleared

Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter

K080255510(k) SpecialCleared May 23, 2008113-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 May 23, 2008 as substantially equivalent to K071285 (Nonin Medical, Inc., 2007) after a 113-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it.

Decided
May 23, 2008
Review
113 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001930 (2000). 4 ancestors in all. 10 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2016: 2 descendants cleared2011: 1 descendant cleared2014: 1 descendant cleared2009: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant clearedK001930 · Model 8500, Hand Held Pulse Oximeter, Model 8500 · Nonin Medical, Inc. · 2000K050056 · Model 2500A Palmsat Pulse Oximeter · Nonin Medical, Inc. · 2005 · recalledK071285 · Digital Pulse Oximeter, Model 7500 · Nonin Medical, Inc. · 2007200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K071285 · Digital Pulse Oximeter, Model 7500 · Nonin Medical, Inc. · 2007K050056 · Model 2500A Palmsat Pulse Oximeter · Nonin Medical, Inc. · 2005 · recalledK001930 · Model 8500, Hand Held Pulse Oximeter, Model 8500 · Nonin Medical, Inc. · 20000
  1. Root · 3 generations backK001930 Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc. · 2000
  2. 2 generations backK050056 Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · Recalled
  3. 1 generation backK071285 Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007
  4. This deviceK080255 Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc. · 2008
  5. Descendant · cites it directly · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
  6. Descendant · cites it directly · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
  7. Descendant · 2 generations on · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
  8. Descendant · cites it directly · 1 of its ownK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016
  9. Descendant · 3 generations on · 0 of its ownK241728 Vios Monitoring System (TM) Model 2050; Vios Central Station…Murata Vios, Inc. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12014: 12016: 22018: 12020: 12024: 22025: 1
2009high 2 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · cites it directly7descendants
  • K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · cites it directly3descendants
  • K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · 2 generations on2descendants
  • K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc. · 2016 · cites it directly1descendant
  • K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001930Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc.2000—
−2K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc.20051
−1K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc.2007—
0 (this device)K080255Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc.2008—
+1K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.2009—
+1K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.20141
+2K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.20184
+1K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors…Nonin Medical, Inc.2016—
+3K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios…Murata Vios, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201410
201620
201810
202010
202420
202510
FIG. 1 — Lineage of K080255, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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
*K071285Digital Pulse Oximeter, Model 7500
Summary page 1
…vice(s): Nonin's Model 7500 Digital Pulse Oximeter manufactured by Nonin Medical, Inc., cleared by the FDA under K071285 on 7/12/07. Device Description: The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabl…
Nonin Medical, Inc.2007—

Also cleared against K071285: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097
K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.20143
K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161
K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160
K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110

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?

  • The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K092101 (Nonin Medical, Inc., 2009) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K071285.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

Indications for use as stated in the FDA summary.

Also cleared against K071285

1 other device cites the same predicate.

  • K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010

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/K080255 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080255: Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080255

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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