Cleared Traditional

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER (K014218) - FDA 510(k) Clearance

Also marketed or referenced as:
DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014218 · Dolphin Medical, Inc. · Anesthesiology device
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Nov 2002
Decision
321d
Days
Class 2
Risk

K014218 is an FDA 510(k) clearance for the OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dolphin Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dolphin Medical, Inc. devices

Submission Details

510(k) Number K014218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date November 07, 2002
Days to Decision 321 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 140d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 176
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K014218.
PM-50 PULSE OXIMETER
K052693 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2006
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · Ge Healthcare · Oct 2005
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766 · Siemens Medical Solutions USA, Inc. · Sep 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193 · Ge Medical Systems Information Technologies · Aug 2002
INFINITY MICRO2+
K012770 · Siemens Medical Solutions USA, Inc. · Jul 2002