# K002036: Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod

- Pathway: 510(k) (Traditional)
- Applicant: Osi Medical, Inc.
- Decided: Apr 17, 2001 after 286 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
No predicates in its family tree.
10 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012626: Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor (2001), 7 descendants of its own
- K012533: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories (2001), 7 descendants of its own
- 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

Source page: https://510kreport.com/device/K002036
Methodology: https://510kreport.com/methodology