510(k) Report

510(k) · Cleared

Cleared

Model 2100 Pulse Oximeter

K031465510(k) SpecialCleared Oct 10, 2003155-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

Dolphin Medical, Inc. · DQA Oximeter

Cleared on Oct 10, 2003 as substantially equivalent to K002036 (Osi Medical, Inc., 2001) and 5 other predicates after a 155-day review. Its family tree reaches back 5 generations to 2001.

Decided
Oct 10, 2003
Review
155 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K002036 (2001). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK002036 · Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod · Osi Medical, Inc. · 2001K012533 · Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories · Osi Medical, Inc. · 2001K020075 · Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter · Dolphin Medical, Inc. · 2002K021959 · Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100 · Dolphin Medical, Inc. · 2002K024235 · Dolphin Medical Stand-Alone Pulse Oximeter · Dolphin Medical, Inc. · 2003200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K024235 · Dolphin Medical Stand-Alone Pulse Oximeter · Dolphin Medical, Inc. · 2003K021959 · Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100 · Dolphin Medical, Inc. · 2002K020075 · Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter · Dolphin Medical, Inc. · 2002K012533 · Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories · Osi Medical, Inc. · 2001K002036 · Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod · Osi Medical, Inc. · 2001−50
  1. Root · 5 generations backK002036 Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and…Osi Medical, Inc. · 2001
  2. 4 generations backK012533 Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and…Osi Medical, Inc. · 2001
  3. 3 generations backK020075 Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2002
  4. 2 generations backK021959 Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc. · 2002
  5. 1 generation backK024235 Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2003
  6. This deviceK031465 Model 2100 Pulse OximeterDolphin Medical, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin…Osi Medical, Inc.2001—
−4K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc.2001—
−3K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc.2002—
−2K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.2002—
−1K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.2003—
0 (this device)K031465Model 2100 Pulse OximeterDolphin Medical, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K031465, 2001–2003Source: 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? (6)

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
*K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical…
Summary page 1
…ccessories is substantially equivalent to the following currently marketed device(s): Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #KO12533, #K012626, #K020075, #KO21959 and #KO24235 The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a p…
Osi Medical, Inc.2001—
*K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc.2001—
*K012626Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor
Summary page 1
…equivalent to the following currently marketed device(s): Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #KO12533, #K012626, #K020075, #KO21959 and #KO24235 The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device,…
Osi Medical, Inc.2001—
*K020075Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter
Summary page 1
…t to the following currently marketed device(s): Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #KO12533, #K012626, #K020075, #KO21959 and #KO24235 The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connectin…
Dolphin Medical, Inc.2002—
*K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.2002—
*K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.2003—

Also cleared against K002036: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 2 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • None of the 6 ancestors has a recall.
  • 6 other devices also cite its predicate K002036.

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 Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an Sp02 sensor).

Indications for use as stated in the FDA summary.

Also cleared against K002036

6 other devices cite the same predicate.

  • K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2003
  • K014218Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable Optical Sensor, Model 210'Dolphin Medical, Inc. · 2002
  • K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc. · 2002
  • K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2002
  • K012626Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical SendorOsi Medical, Inc. · 2001
  • K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc. · 2001

More from Dolphin Medical, Inc.

12 FDA decisions under this applicant name. See the company

  • K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension CablesDolphin Medical, Inc. · 2006
  • K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc. · 2004
  • K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260…Dolphin Medical, Inc. · 2004
  • K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc. · 2003
  • K030629Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc. · 2003

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/K031465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031465: Model 2100 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/K031465

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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