510(k) · Cleared
ClearedDolphin Medical Stand-Alone Pulse Oximeter, Model 2100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dolphin Medical, Inc. · DQA Oximeter
Cleared on Jul 11, 2002 as substantially equivalent to K002036 (Osi Medical, Inc., 2001) and 3 other predicates after a 27-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it.
- Decided
- Jul 11, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K002036 (2001). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002036 Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and…Osi Medical, Inc. · 2001
- 2 generations backK012533 Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and…Osi Medical, Inc. · 2001
- 1 generation backK020075 Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2002
- This deviceK021959 Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK024235 Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK030629 Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK040380 Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc. · 2004
- Descendant · 4 generations on · 0 of its ownK242290 DormoTech NLabDormotech Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK031465 Model 2100 Pulse OximeterDolphin Medical, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- 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
- K242290DormoTech NLabDormotech Medical, Ltd. · 2025 · 4 generations on0descendants
- K031465Model 2100 Pulse OximeterDolphin Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002036 | Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin… | Osi Medical, Inc. | 2001 | — |
| −2 | K012533 | Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories | Osi Medical, Inc. | 2001 | — |
| −1 | K020075 | Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter | Dolphin Medical, Inc. | 2002 | — |
| 0 (this device) | K021959 | Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100 | Dolphin Medical, Inc. | 2002 | — |
| +1 | K024235 | Dolphin Medical Stand-Alone Pulse Oximeter | Dolphin Medical, Inc. | 2003 | — |
| +2 | K030629 | Dolphin Medical 2150 Handheld Pulse Oximeter | Dolphin Medical, Inc. | 2003 | — |
| +3 | K040380 | Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420 | Dolphin Medical, Inc. | 2004 | — |
| +4 | K242290 | DormoTech NLab | Dormotech Medical, Ltd. | 2025 | — |
| +1 | K031465 | Model 2100 Pulse Oximeter | Dolphin Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K002036 | Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical…Summary page 1…cessories is substantially equivalent to the following currently marketed device(s): 0 Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #K012533, #K012626, and #KO20075 The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alon… | 2001 |
| * | K012533 | Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and AccessoriesSummary page 1…antially equivalent to the following currently marketed device(s): 0 Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #K012533, #K012626, and #KO20075 The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecti… | 2001 |
| * | K012626 | Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical SendorSummary page 1…quivalent to the following currently marketed device(s): 0 Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036, #K012533, #K012626, and #KO20075 The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable,… | 2001 |
| * | K020075 | Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter | 2002 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 year and passes through 2 companies; a new generation was cleared every 5 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K024235 (Dolphin Medical, Inc., 2003) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K002036.
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 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.
https://510kreport.com/device/K021959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021959: Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021959
Report an extraction error
Are you the manufacturer?
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