Cleared Traditional

K042449 - DOLPHIN INFLATION DEVICE

K042449 is an FDA 510(k) clearance for DOLPHIN INFLATION DEVICE, manufactured by Sedat S.A.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K042449 · Sedat S.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
221d
Days
Class 2
Risk

K042449 is an FDA 510(k) clearance for the DOLPHIN INFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Sedat S.A. (Temecula, US). The FDA issued a Cleared decision on April 18, 2005 after a review of 221 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sedat S.A. devices

FDA 510(k) Submission Details - K042449

510(k) Number K042449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2004
Decision Date April 18, 2005
Days to Decision 221 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 125d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 42
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K042449.
OXTI INFLATION DEVICE
K122152 · Oxti Corporation · Dec 2012
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012
ENCORE 26 ADVANTAGE KIT
K120694 · Boston Scientific Corp · Apr 2012
VICEROY INFLATION DEVICE
K040138 · Merit Medical Systems, Inc. · Feb 2004
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · Vanguard Medical Concepts, Inc. · Jan 2002
INTELLISYSTEM II COLOR MONITOR
K993341 · Merit Medical Systems, Inc. · Oct 1999