# K021959: Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100

- Pathway: 510(k) (Special)
- Applicant: Dolphin Medical, Inc.
- Decided: Jul 11, 2002 after 27 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: 3 generations back to K002036 (2001). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 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) Summary page 1.
- 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)

## Most influential descendants
- K024235: Dolphin Medical Stand-Alone Pulse Oximeter (2003), 4 descendants of its own
- K030629: Dolphin Medical 2150 Handheld Pulse Oximeter (2003), 2 descendants of its own
- K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420 (2004), 1 descendant of its own
- K242290: DormoTech NLab (2025), 0 descendants of its own
- K031465: Model 2100 Pulse Oximeter (2003), 0 descendants of its own

## 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/K021959
Methodology: https://510kreport.com/methodology