510(k) · Cleared
ClearedDolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dolphin Medical, Inc. · DQA Oximeter
Cleared on Mar 20, 2002 as substantially equivalent to K960251 (Aristo Medical Products, Inc., 1996) after a 195-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Mar 20, 2002
- Review
- 195 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960251 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK960251 Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat…Aristo Medical Products, Inc. · 1996
- This deviceK012989 Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Dolphin Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK030952 Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312…Dolphin Medical, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK032947 Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK060524 Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable…Dolphin Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK033876 Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321…Dolphin Medical, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313…Dolphin Medical, Inc. · 2003 · cites it directly3descendants
- K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc. · 2003 · 2 generations on1descendant
- K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension…Dolphin Medical, Inc. · 2006 · cites it directly0descendants
- K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342…Dolphin Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960251 | Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable… | Aristo Medical Products, Inc. | 1996 | — |
| 0 (this device) | K012989 | Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070 | Dolphin Medical, Inc. | 2002 | — |
| +1 | K030952 | Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric… | Dolphin Medical, Inc. | 2003 | — |
| +2 | K032947 | Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210 | Dolphin Medical, Inc. | 2003 | — |
| +1 | K060524 | Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and… | Dolphin Medical, Inc. | 2006 | — |
| +1 | K033876 | Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323… | Dolphin Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960251 | Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable Finger SensorSummary page 2…00 Oximetry Sensors Predicate Devices Sensor Name Dolphin Model | Aristo Model | Original 510(k) ( Predicate Device) BCl| Reusable Dolphin 2000 2050 222 K960251 Oximetry Sensor BCl Adult Disposable 2351 221-1 K960251 Dolphin 2000 Oximetry Sensor BCl Pediatric Disposable 2352 221-2 K960251… | 1996 |
| * | — | Aristo oximetry sensors manufactured by Opto Sensors (M) Sdn. Bhd. Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030952 | Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313… | 2003 | 3 |
| K060524 | Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension… | 2006 | 0 |
| K033876 | Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342… | 2004 | 0 |
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, K030952 (Dolphin Medical, Inc., 2003) has gone furthest, with 3 descendants of its own.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012989: Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012989
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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