# K012989: Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070

- Pathway: 510(k) (Traditional)
- Applicant: Dolphin Medical, Inc.
- Decided: Mar 20, 2002 after 195 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960251 (1996). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960251: Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable Finger Sensor, Aristo Medical Products, Inc. (1996) Summary page 2.
- (no number) Aristo oximetry sensors manufactured by Opto Sensors (M) Sdn. Bhd.: named in the summary without a submission number

## Most influential descendants
- K030952: Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421 (2003), 3 descendants of its own
- K032947: Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210 (2003), 1 descendant of its own
- K060524: Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables (2006), 0 descendants of its own
- K033876: Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 and 2422 (2004), 0 descendants of its own

## Indications for use
The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

Source page: https://510kreport.com/device/K012989
Methodology: https://510kreport.com/methodology