# K122980: Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ, Glidesheath Slender Model RM * RS6J10PQ

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Dec 11, 2012 after 76 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: 4 generations back to K954234 (1995). 9 ancestors in all.
12 later devices descend from it; 2 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082644: Glidesheath, Terumo Medical Corp. (2008) Summary page 1.

## Most influential descendants
- K142183: Glidesheath Slender (2014), 8 descendants of its own
- K181237: Glidesheath Slender Tibial Pedal Kit (2018), 2 descendants of its own
- K132592: Flexor Radial Hydrophilic Introducer Access Set (2014), 2 descendants of its own
- K173831: Glidesheath Slender (2018), 1 descendant of its own
- K152044: Flexor Radial Hydrophilic Introducer Access Set (2015), 1 descendant of its own

## Indications for use
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Source page: https://510kreport.com/device/K122980
Methodology: https://510kreport.com/methodology