# K121504: Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets

- Pathway: 510(k) (Traditional)
- Applicant: Togo Medikit Co., Ltd.
- Decided: Sep 27, 2012 after 129 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K954234 (1995). 2 ancestors in all.
9 later devices descend from it; 3 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)
- K052557: Super Sheath Introducer Sheath, Togo Medikit Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K123430: Microslider Tearaway Introducer Set (2013), 5 descendants of its own
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (2016), 4 descendants of its own
- K170020: Peel-Away Introducer Set (2017), 1 descendant of its own
- K141070: Super Sheath (2015), 1 descendant of its own
- K261950: Health Line Tearaway Introducer (2026), 0 descendants of its own

## Indications for use
The Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

Source page: https://510kreport.com/device/K121504
Methodology: https://510kreport.com/methodology