510(k) Report

FDA applicant

Dolphin Medical, Inc.

Highlands Ranch, CO12 decisions2002–20060 recalls

FDA records 12 decisions for Dolphin Medical, Inc. (Highlands Ranch, CO) from 2002 to 2006: 12 510(k) clearances. All are in product code DQA (Oximeter). Its devices cite 36 predicates, 16 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Dolphin Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dolphin Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dolphin Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQAOximeter12decisions

Whose devices does it build on?

Its devices cite 36 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 16 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020075Modification to Osi Medical Dolphin Stand-Alone Pulse OximeterDolphin Medical, Inc. · 20024cite it
  • K012989Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Dolphin Medical, Inc. · 20023cite it
  • K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421Dolphin Medical, Inc. · 20033cite it
  • K021959Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100Dolphin Medical, Inc. · 20022cite it
  • K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 20032cite it
  • K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc. · 20041cites it

What has FDA decided for it lately?

  • K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension CablesDolphin Medical, Inc. · 2006
  • K040380Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420Dolphin Medical, Inc. · 2004
  • K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260…Dolphin Medical, Inc. · 2004
  • K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc. · 2003
  • K031465Model 2100 Pulse OximeterDolphin Medical, Inc. · 2003
  • K030629Dolphin Medical 2150 Handheld Pulse OximeterDolphin Medical, Inc. · 2003
  • K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421Dolphin Medical, Inc. · 2003
  • K024235Dolphin Medical Stand-Alone Pulse OximeterDolphin Medical, Inc. · 2003

All 12 as Dolphin Medical, Inc. →

Other applicant names beginning “Dolphin”

FDA records each applicant name separately; these may or may not be the same firm.

Dolphin Medical Technologies, Inc. 2Dolphin Medical Imaging, LLC 1Dolphin Imaging Systems 1