# K014218: Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable Optical Sensor, Model 210'

- Pathway: 510(k) (Traditional)
- Applicant: Dolphin Medical, Inc.
- Decided: Nov 7, 2002 after 321 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 K001995 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002036: Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod, Osi Medical, Inc. (2001) Summary page 1.
- K001995: Spiroxcard Diagnostic Spirometer and Pulse Oximeter, Qrs Diagnostic, LLC (2000)

## Indications for use
The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).

Source page: https://510kreport.com/device/K014218
Methodology: https://510kreport.com/methodology