Cleared Traditional

K030629 - DOLPHIN MEDICAL 2150 HANDHELD PULSE OXI...

K030629 is an FDA 510(k) clearance for DOLPHIN MEDICAL 2150 HANDHELD PULSE OXI..., 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 189-day FDA review.

K030629 · Dolphin Medical, Inc. · Anesthesiology device
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Sep 2003
Decision
189d
Days
Class 2
Risk

K030629 is an FDA 510(k) clearance for the DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dolphin Medical, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on September 4, 2003 after a review of 189 days - an extended review cycle.

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. Standard predicate reliance. 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 - K030629

510(k) Number K030629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2003
Decision Date September 04, 2003
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
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 K030629.
SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
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DRAEGER MICRO2+ AND MASIMO MINISAT
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MODEL 3100 WRISTOX PULSE OXIMETER
K030668 · Nonin Medical, Inc. · Oct 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044 · Nonin Medical, Inc. · Jul 2003
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K030973 · Philips Medical Systems · Jul 2003
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003