# K031465: Model 2100 Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Dolphin Medical, Inc.
- Decided: Oct 10, 2003 after 155 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 K002036 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K012533: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories, Osi Medical, Inc. (2001)
- K012626: Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor, Osi Medical, Inc. (2001) Summary page 1.
- K020075: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter, Dolphin Medical, Inc. (2002) Summary page 1.
- K021959: Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100, Dolphin Medical, Inc. (2002)
- K024235: Dolphin Medical Stand-Alone Pulse Oximeter, Dolphin Medical, Inc. (2003)

## Indications for use
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).

Source page: https://510kreport.com/device/K031465
Methodology: https://510kreport.com/methodology