Cleared Special

K040380 - DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420

K040380 is an FDA 510(k) clearance for DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSA..., manufactured by Dolphin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 196-day FDA review.

K040380 · Dolphin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
196d
Days
Class 2
Risk

K040380 is an FDA 510(k) clearance for the DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dolphin Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 196 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040380

510(k) Number K040380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date August 31, 2004
Days to Decision 196 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 140d · This submission: 196d
Pathway characteristics
Modification to existing cleared device.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K040380.
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K041644 · Elekon Industries U.S.A., Inc. · Jul 2004