510(k) Report

510(k) · Cleared

Recalled · 2007

Model 2500A Palmsat Pulse Oximeter

K050056510(k) TraditionalCleared Jun 21, 2005161-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

Nonin Medical, Inc. · DQA Oximeter

Cleared on Jun 21, 2005 as substantially equivalent to K001930 (Nonin Medical, Inc., 2000) and 1 other predicate after a 161-day review. Its family tree reaches back 1 generation to 2000. 62 later devices descend from it. It has been recalled once.

Decided
Jun 21, 2005
Review
161 days
Class
Class II
Product code
DQA
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K001930 (2000). 2 ancestors in all. 62 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2010: 4 descendants cleared2012: 1 descendant cleared2007: 2 descendants cleared2009: 2 descendants cleared2008: 1 descendant cleared2011: 3 descendants cleared2014: 1 descendant cleared2018: 6 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2016: 4 descendants cleared2019: 3 descendants cleared2013: 1 descendant cleared2020: 7 descendants cleared2025: 10 descendants cleared2026: 6 descendants cleared2024: 4 descendants cleared2023: 2 descendants cleared2022: 2 descendants clearedK001930 · Model 8500, Hand Held Pulse Oximeter, Model 8500 · Nonin Medical, Inc. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 12 descendants3 generations forward: 26 descendants4 generations forward: 13 descendants5 generations forward: 3 descendants K001930 · Model 8500, Hand Held Pulse Oximeter, Model 8500 · Nonin Medical, Inc. · 20000+5
  1. Root · 1 generation backK001930 Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc. · 2000
  2. This deviceK050056 Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005
  3. Descendant · cites it directly · 29 of its ownK071285 Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007
  4. Descendant · cites it directly · 22 of its ownK100077 Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model…Solaris Medical Technology, Inc. · 2010
  5. Descendant · 2 generations on · 17 of its ownK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
  6. Descendant · 2 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
  7. Descendant · cites it directly · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2007: 22008: 12009: 22010: 42011: 32012: 12013: 12014: 12015: 12016: 42017: 22018: 62019: 32020: 72022: 22023: 22024: 42025: 102026: 6
2007high 10 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 62 · See all
  • K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007 · cites it directly29descendants
  • K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010 · cites it directly22descendants
  • K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010 · 2 generations on17descendants
  • K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 2 generations on14descendants
  • K113165Mini-MedicAthena Gtx · 2012 · cites it directly13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001930Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc.2000—
0 (this device)K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc.2005—
+1K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc.2007—
+1K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.2010—
+2K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx2010—
+2K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.2015—
+1K113165Mini-MedicAthena Gtx2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200810
200920
201040
201130
201210
201310
201410
201510
201640
201720
201860
201930
202070
202220
202320
202440
2025100
202660
FIG. 1 — Lineage of K050056, 2000–2026Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K001930Model 8500, Hand Held Pulse Oximeter, Model 8500
Summary page 1
…CFR 870.2700 Product Code: 74 DQA Predicate Device(s): The predicate devices are the Model 2500 PaImSAT® Pulse Oximeter, K001930, cleared on July 22, 2000 and the Model 2500 PlamSAT® Pulse Oximeter with 2…
Nonin Medical, Inc.2000—
*K002690Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500
Summary page 1
…Pulse Oximeter, K001930, cleared on July 22, 2000 and the Model 2500 PlamSAT® Pulse Oximeter with 2500C and 2500B, K002690, cleared on October 11, 2000. Device Description: The Model 2500A PaImSAT® with Alarms is a d…
Nonin Medical, Inc.20002

Also cleared against K001930: 2 other devices →

What descends from it? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc.200729
K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022
K113165Mini-MedicAthena Gtx201213
K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097
K071610Mediaid Pulse Oximeter M30 and M34Mediaid, Inc.20074
K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc.20102
K093306Single-Patient Use Disposable SensorNonin Medical, Inc.20100
K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 11, 2007Not classifiedZ-0843-2008Error in labelingIncorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K071285 (Nonin Medical, Inc., 2007) has gone furthest, with 29 descendants of its own.
  • 2 other devices also cite its predicate K001930.

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® Model 2500A Pulse Oximeter with Alarms is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. It is intended for spot-checking and / or continuous monitoring of patients during motion and no motion conditions, and for patients who are well or poorly perfused.

Indications for use as stated in the FDA summary.

Also cleared against K001930

2 other devices cite the same predicate.

  • K061896Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02 Sensors, Model…Mediaid, Inc. · 2007
  • K033998Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp. · 2004

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/K050056 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050056: Model 2500A Palmsat 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/K050056

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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