# Osi Medical, Inc.

- Location (FDA's records): Tampa, FL
- FDA decisions: 3 (2001–2001): 3 510(k) clearances
- Product codes: DQA (3)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 15 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Dolphin Medical, Inc.: 13 (https://510kreport.com/company/dolphin-medical)

## Its most-cited devices
- K002036: Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod (2001), cited by 7
- K012533: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories (2001), cited by 4
- K012626: Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor (2001), cited by 4

## Recent decisions
- K012626: Osi Medical Dolphin Stand-Alone Pulse Oximeter & Digital Dolphin Disposable Optical Sendor (Nov 2, 2001)
- K012533: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories (Aug 22, 2001)
- K002036: Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical Sensor, Clip-on Finger Probe, Mod (Apr 17, 2001)

Source page: https://510kreport.com/company/osi-medical