# K111606: Pinnacle Precision Access System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Oct 3, 2011 after 116 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954234 (1995). 10 ancestors in all.
7 later devices descend from it; 3 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954234: Radifocus Introducer II Kit, Terumo Medical Corp. (1995) Summary page 2.
- K102008: Glidesheath, Terumo Medical Corp. (2010) Summary page 8.

## Most influential descendants
- K123475: Shoocin Introducer Kit (2014), 3 descendants of its own
- K152177: SonoStik IV Guide Wire Introducer (2015), 1 descendant of its own
- K140768: Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant Introducer Kit, Type IV Brilliant (2014), 1 descendant of its own
- K252441: Primero Safe Access System (2025), 0 descendants of its own
- K243061: SonoStik Guide Wire Introducer (2024), 0 descendants of its own

## Recalls of this device
- Mar 16, 2016 · Class II · Z-2738-2016: Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremen

## Indications for use
The Pinnacle Precision Access System is used to facilitate planing a catheter through the skin into a vein or artery. The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.

Source page: https://510kreport.com/device/K111606
Methodology: https://510kreport.com/methodology