510(k) Report

510(k) · Cleared

Recalled · 2007

Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500

K002690510(k) SpecialCleared Oct 11, 200043-day reviewClass II21 CFR 870.2700Recalls 2

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 Oct 11, 2000 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 112 later devices descend from it. It has been recalled 2 times.

Decided
Oct 11, 2000
Review
43 days
Class
Class II
Product code
DQA
Recalls
2
Predicates
0

112 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2010: 7 descendants cleared2003: 2 descendants cleared2007: 4 descendants cleared2005: 3 descendants cleared2009: 4 descendants cleared2004: 2 descendants cleared2012: 5 descendants cleared2014: 3 descendants cleared2018: 8 descendants cleared2011: 10 descendants cleared2021: 1 descendant cleared2017: 6 descendants cleared2008: 4 descendants cleared2015: 2 descendants cleared2016: 5 descendants cleared2019: 3 descendants cleared2020: 8 descendants cleared2025: 11 descendants cleared2024: 5 descendants cleared2013: 7 descendants cleared2026: 6 descendants cleared2023: 3 descendants cleared2022: 3 descendants cleared200020052010201520202025
  1. This deviceK002690 Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Nonin Medical, Inc. · 2000
  2. Descendant · cites it directly · 62 of its ownK050056 Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · Recalled
  3. Descendant · cites it directly · 39 of its ownK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
  4. Descendant · 2 generations on · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
  5. Descendant · 2 generations on · 29 of its ownK071285 Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007
  6. Descendant · 3 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2003: 22004: 22005: 32007: 42008: 42009: 42010: 72011: 102012: 52013: 72014: 32015: 22016: 52017: 62018: 82019: 32020: 82021: 12022: 32023: 32024: 52025: 112026: 6
2003high 11 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 112 · See all
  • K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · cites it directly62descendants
  • K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003 · cites it directly39descendants
  • K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · 2 generations on34descendants
  • K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007 · 2 generations on29descendants
  • K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 3 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002690Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Nonin Medical, Inc.2000—
+1K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc.20051
+1K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.2003—
+2K041308Remotenurse Patient Monitoring SystemWebvmc, LLC2004—
+2K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc.2007—
+3K080798Intel Health Guide, Model: PHS6000Intel Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200420
200530
200740
200840
200940
201070
2011100
201250
201370
201430
201520
201650
201760
201880
201930
202080
202110
202230
202330
202450
2025110
202660
FIG. 1 — Lineage of K002690, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (112)

See all 112

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

NumberDeviceApplicantDecidedDescendants
K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc.200562
K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd.200339
K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097
K030668Model 3100 Wristox Pulse OximeterNonin Medical, Inc.20037
K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc.20102
K093306Single-Patient Use Disposable SensorNonin Medical, Inc.20100
K061896Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02…Mediaid, Inc.20070

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 15, 2007Not classifiedZ-1092-2008Environmental controlForeign material: Glass fragments may present in the plastic bag material used to ship components.
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?

  • Of its descendants, K050056 (Nonin Medical, Inc., 2005) has gone furthest, with 62 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

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—

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/K002690 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002690: Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002690

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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