# K060524: Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables

- Pathway: 510(k) (Special)
- Applicant: Dolphin Medical, Inc.
- Decided: Jun 15, 2006 after 108 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: 5 generations back to K962603 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030952: Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421, Dolphin Medical, Inc. (2003) Summary page 1.
- K012989: Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070, Dolphin Medical, Inc. (2002) Summary page 1.
- K970769: Comsat Adult,Pediatric,Infant,Neonatal,Disposable Sensor/Comsat Reusable Finger Sensor, Aristo Medical (1997)

## 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/K060524
Methodology: https://510kreport.com/methodology