# K123135: Axera 2 Access System Model AXE200

- Pathway: 510(k) (Traditional)
- Applicant: Arstasis, Inc.
- Decided: Jan 28, 2013 after 115 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: 10 generations back to K945616 (1995). 18 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121521: Axera Access System, Arstasis, Inc. (2012) Summary page 1.

## Most influential descendants
- K123618: Axera 2 Access System (2013), 5 descendants of its own
- K132263: Axera 2 Access System (2013), 4 descendants of its own
- K140287: Axera RX Access System (2014), 1 descendant of its own
- K140201: Axera 2 Access System (2014), 1 descendant of its own
- K151877: MicroTract Access System (2015), 0 descendants of its own

## Indications for use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Source page: https://510kreport.com/device/K123135
Methodology: https://510kreport.com/methodology