# K012406: Access Sequestration System

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Mar 26, 2002 after 239 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963759 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963759: Dideco Compact-a and Compact-M Autotransfusion Systems, Sorin Biomedical, Inc. (1998) Summary page 2.

## Most influential descendants
- K022348: Access Concentration System, Model Acc-100, Access  Disposable Set, Model Ads-2000 (2002), 0 descendants of its own

## Indications for use
The Interpore Cross International Access™ Sequestration System is intended to separate and collect an autologous plasma fraction rich in platelets and white cells, from the patient’s whole blood perioperative to a surgical procedure.

Source page: https://510kreport.com/device/K012406
Methodology: https://510kreport.com/methodology