# K111426: Euclid (TM) Tier 1-GW Access System

- Pathway: 510(k) (Traditional)
- Applicant: Houston Medical Robotics
- Decided: Mar 1, 2012 after 283 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850478 (1985). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081697: The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006, Access Scientific, Inc. (2008) Summary page 1.
- K093713: Ultrasound General Purpose Guidance System, Civco Medical Instruments (2010) Summary page 1.
- K093022: The Picc Wand Peelable Safety Introducer, Access Scientific, Inc. (2010) Summary page 2.

## Indications for use
The EuclidTM Tier 1 Mini Access System is used to facilitate the placing of a needle and guidewire into a targeted anatomical location.

Source page: https://510kreport.com/device/K111426
Methodology: https://510kreport.com/methodology