# K082755: Sedat Flamingo

- Pathway: 510(k) (Special)
- Applicant: Sedat
- Decided: Dec 15, 2008 after 87 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854261 (1985). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042449: Dolphin Inflation Device, Sedat S.A. (2005) Summary page 1.

## Most influential descendants
- K152387: Fluent Inflation Device (2015), 1 descendant of its own
- K162272: Fluent inflation device (2016), 0 descendants of its own
- K123831: Ophtacath Kit (2013), 0 descendants of its own

## Recalls of this device
- May 10, 2012 · Class II · Z-2089-2014: Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air en

## Indications for use
The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Source page: https://510kreport.com/device/K082755
Methodology: https://510kreport.com/methodology