Cleared Traditional

K014218 - OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE ...

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

K014218 is an FDA 510(k) clearance for OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE ..., manufactured by Dolphin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K014218 · Dolphin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K014218

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.

DQA Device Classification - Class 2, Special Controls

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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K014218.
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
K030930 · Nellcor Puritan Bennett, Inc. · May 2003
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K031330 · Masimo Corp. · May 2003
MICROCAP PLUS/NPB-75
K024300 · Oridion Medical 1987 , Ltd. · Apr 2003
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
K021955 · Datex-Ohmeda, Inc. · Oct 2002
ATLAS MONITOR, MODELS 200,210,220
K022084 · Welch Allyn, Inc. · Sep 2002
NELLCOR N-200 PULSE OXIMETER, MODEL N-200
K022819 · Nellcor Puritan Bennett, Inc. · Sep 2002