Cleared Special

K082755 - SEDAT FLAMINGO

K082755 is an FDA 510(k) clearance for SEDAT FLAMINGO, manufactured by Sedat. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Special 510(k) pathway after a 87-day FDA review.

K082755 · Sedat · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
87d
Days
Class 2
Risk

K082755 is an FDA 510(k) clearance for the SEDAT FLAMINGO. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Sedat (San Diego, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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. Low regulatory complexity profile. 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 - K082755

510(k) Number K082755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2008
Decision Date December 15, 2008
Days to Decision 87 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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 55
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K082755.
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K120694 · Boston Scientific Corp · Apr 2012
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K102648 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · Jul 2011
QL LOCKING SYRINGE
K060643 · Atrion Medical Products, Inc. · Jul 2006
DOLPHIN INFLATION DEVICE
K042449 · Sedat S.A. · Apr 2005
VICEROY INFLATION DEVICE
K040138 · Merit Medical Systems, Inc. · Feb 2004
K082755 · SEDAT FLAMINGO
Download PDF FDA Summary Sedat