# K011526: Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jun 14, 2001 after 28 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 4 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090728: Hyperglide Occlusion Balloon System (2009), 10 descendants of its own
- K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104 (2009), 8 descendants of its own
- K110741: Scepter C Occlusion Balloon Catheter (2011), 4 descendants of its own
- K113698: Scepter XC Occlusion Balloon Catheter (2012), 3 descendants of its own
- K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 (2009), 3 descendants of its own

Source page: https://510kreport.com/device/K011526
Methodology: https://510kreport.com/methodology