# K012533: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Osi Medical, Inc.
- Decided: Aug 22, 2001 after 16 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 K002036 (2001). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
0 of 9 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.

## Most influential descendants
- K020075: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter (2002), 6 descendants of its own
- K021959: Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100 (2002), 5 descendants of its own
- 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

## Indications for use
The OS! Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO.) and pulse rate {measured by an SpO; sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult and pediatric patients who are well or poorly perfused in hospitals, hospital-type facilites and home environments. The OSI Medical's sensor(s) are intendedfindicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following: Digital Dolphin Disposable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin Reusable Sensors intended for adults / pediatrics greater than 66.14 Ibs. (30kg). Digital Dolphin 110 Extension Cable The OS| Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OSI Medical Dolphin Stand-Alone Pulse Oximeter.

Source page: https://510kreport.com/device/K012533
Methodology: https://510kreport.com/methodology