# Dolphin Medical, Inc.

- Location (FDA's records): Highlands Ranch, CO
- FDA decisions: 12 (2002–2006): 12 510(k) clearances
- Product codes: DQA (12)
- Predicates its devices cite: 36 (16 its own); citations of its devices by later devices: 17 (16 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Osi Medical, Inc.: 13 (https://510kreport.com/company/osi-medical)
- Aristo Medical Products, Inc.: 2 (https://510kreport.com/company/aristo-medical-products)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Nellcor, Inc.: 1 (https://510kreport.com/company/nellcor)
- Aristo Medical: 1 (https://510kreport.com/company/aristo-medical)
- Qrs Diagnostic, LLC: 1 (https://510kreport.com/company/qrs-diagnostic)

## Firms that cite its devices most
- Dormotech Medical, Ltd.: 1 (https://510kreport.com/company/dormotech-medical)

## Its most-cited devices
- K020075: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter (2002), cited by 4
- K012989: Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070 (2002), cited by 3
- K030952: Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421 (2003), cited by 3
- K021959: Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100 (2002), cited by 2
- K024235: Dolphin Medical Stand-Alone Pulse Oximeter (2003), cited by 2
- K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420 (2004), cited by 1

## Recent decisions
- K060524: Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables (Jun 15, 2006)
- K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420 (Aug 31, 2004)
- K033876: Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 and 2422 (Mar 11, 2004)
- K032947: Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210 (Oct 17, 2003)
- K031465: Model 2100 Pulse Oximeter (Oct 10, 2003)
- K030629: Dolphin Medical 2150 Handheld Pulse Oximeter (Sep 4, 2003)
- K030952: Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421 (May 19, 2003)
- K024235: Dolphin Medical Stand-Alone Pulse Oximeter (Mar 17, 2003)

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