# K042449: Dolphin Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Sedat S.A.
- Decided: Apr 18, 2005 after 221 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854261 (1985). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961471: Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve), Advanced Cardiovascular Systems, Inc. (1996) Summary page 4.
- K040498: Myshell, Sedat S.A. (2004) Summary page 4.

## Most influential descendants
- K082755: Sedat Flamingo (2008), 3 descendants of its own
- 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
- K122152: Oxti Inflation Device (2012), 0 descendants of its own

## Recalls of this device
- Jun 7, 2017 · Class II · Z-2639-2017: Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
- Apr 12, 2017 · Class II · Z-2180-2017: The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of m
- Apr 5, 2017 · Class II · Z-1891-2017: Complaints regarding broken blister.
- Oct 6, 2014 · Class II · Z-0876-2015: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

## Indications for use
DOLPHIN lnflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Source page: https://510kreport.com/device/K042449
Methodology: https://510kreport.com/methodology