Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 and 2422

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K033876 ↗

FDA Product Code

DQA

Models / Variants

2020

2040

2060

2070

2321

2323

2341

2342

2343

2344

2220

2260

2422

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421

  Class II

  FDA 510(k) K030952 Active Cleared 19 May 2003

• Dolphin Medical 2150 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K030629 Active Cleared 4 Sep 2003

• Dolphin Medical Stand-Alone Pulse Oximeter

  Class II

  FDA 510(k) K024235 Active Cleared 17 Mar 2003

• Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420

  Class II

  FDA 510(k) K040380 Active Cleared 31 Aug 2004

• Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070

  Class II

  FDA 510(k) K012989 Active Cleared 20 Mar 2002

• Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210

  Class II

  FDA 510(k) K032947 Active Cleared 17 Oct 2003

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