510(k) · Cleared
ClearedDolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dolphin Medical, Inc. · DQA Oximeter
Cleared on Jun 15, 2006 as substantially equivalent to K030952 (Dolphin Medical, Inc., 2003) and 2 other predicates after a 108-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jun 15, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K962603 (1997). 10 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK030952 Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312…Dolphin Medical, Inc. · 2003
- This deviceK060524 Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable…Dolphin Medical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K030952 | Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric… | Dolphin Medical, Inc. | 2003 | — |
| 0 (this device) | K060524 | Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and… | Dolphin Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030952 | Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313…Summary page 1…Predicate Model # 5§10(k ~# Model# 51 0(k)# 2030 Sensor Model 201 0 K030952 ______ 2331 Sensor 2351 K01 2989 251-1 K9-70769 2332 Sensor… | 2003 |
| * | K012989 | Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Summary page 1…Model# 51 0(k)# 2030 Sensor Model 201 0 K030952 ______ 2331 Sensor 2351 K01 2989 251-1 K9-70769 2332 Sensor __ 2352 -K-01 2989 -2-51--2… | 2002 |
| * | K970769 | Comsat Adult,Pediatric,Infant,Neonatal,Disposable Sensor/Comsat Reusable Finger Sensor | 1997 |
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 9 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K030952.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060524 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060524: Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060524
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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