510(k) Report

510(k) · Cleared

Cleared

Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories

K012533510(k) TraditionalCleared Aug 22, 200116-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

Osi Medical, Inc. · DQA Oximeter

Cleared on Aug 22, 2001 as substantially equivalent to K002036 (Osi Medical, Inc., 2001) after a 16-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.

Decided
Aug 22, 2001
Review
16 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002036 (2001). 7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2003: 3 descendants cleared2004: 1 descendant cleared2025: 1 descendant clearedK002036 · Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod · Osi Medical, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K002036 · Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod · Osi Medical, Inc. · 20010
  1. Root · 1 generation backK002036 Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and…Osi Medical, Inc. · 2001
  2. This deviceK012533 Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and…Osi Medical, Inc. · 2001
  3. Descendant · cites it directly · 6 of its ownK020075 Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2002
  4. Descendant · cites it directly · 5 of its ownK021959 Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc. · 2002
  5. Descendant · cites it directly · 4 of its ownK024235 Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2003
  6. Descendant · 2 generations on · 2 of its ownK030629 Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc. · 2003
  7. Descendant · 3 generations on · 1 of its ownK040380 Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc. · 2004

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 22003: 32004: 12025: 1
2002high 3 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2002 · cites it directly6descendants
  • K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc. · 2002 · cites it directly5descendants
  • K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2003 · cites it directly4descendants
  • K030629Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc. · 2003 · 2 generations on2descendants
  • K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc. · 2004 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin…Osi Medical, Inc.2001—
0 (this device)K012533Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesOsi Medical, Inc.2001—
+1K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc.2002—
+1K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.2002—
+1K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.2003—
+2K030629Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc.2003—
+3K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200330
200410
202510
FIG. 1 — Lineage of K012533, 2001–2025Source: 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
*K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical…
Summary page 1
…Accessories is substantially equivalent to the following currently marketed device(s): o 0S| Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036. The OSI Medical Dolphin Pulse Oximeter and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(…
Osi Medical, Inc.2001—

Also cleared against K002036: 6 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc.20026
K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc.20025
K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc.20034
K031465Model 2100 Pulse OximeterDolphin Medical, Inc.20030

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, K020075 (Dolphin Medical, Inc., 2002) has gone furthest, with 6 descendants of its own.
  • 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 OS! Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO.) and pulse rate {measured by an SpO; sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult and pediatric patients who are well or poorly perfused in hospitals, hospital-type facilites and home environments. The OSI Medical's…

Read the full statement (140 words)

The OS! Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO.) and pulse rate {measured by an SpO; sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult and pediatric patients who are well or poorly perfused in hospitals, hospital-type facilites and home environments.

The OSI Medical's sensor(s) are intendedfindicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following:

Digital Dolphin Disposable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg).

Digital Dolphin Reusable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg).

Digital Dolphin 110 Extension Cable

The OS| Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OSI Medical Dolphin Stand-Alone Pulse Oximeter.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K002036

6 other devices cite the same predicate.

  • K031465Model 2100 Pulse OximeterDolphin Medical, Inc. · 2003
  • 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

More from Osi Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K012626Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical SendorOsi Medical, Inc. · 2001
  • K002036Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on…Osi Medical, Inc. · 2001

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/K012533 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012533: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012533

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026