# K040498: Myshell

- Pathway: 510(k) (Traditional)
- Applicant: Sedat S.A.
- Decided: Jul 2, 2004 after 127 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854261 (1985). 2 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991102: Copilot Bleedback Control Valve, Model 1003331, Guidant Corp. (1999) Summary page 1.

## Most influential descendants
- K042449: Dolphin Inflation Device (2005), 5 descendants of its own
- K082755: Sedat Flamingo (2008), 3 descendants of its own
- K072552: Merit Medical Systems, Inc., Guide Wire Torque Device (2007), 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

## Indications for use
MYSHELL and its accessories are indicated for assisting, manipulating and maintaining used a seal around diagnostic/interventional devices with an outside diameter <9F (.098") in interventional procedures.

Source page: https://510kreport.com/device/K040498
Methodology: https://510kreport.com/methodology