# K022348: Access Concentration System, Model Acc-100, Access  Disposable Set, Model Ads-2000

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Aug 15, 2002 after 27 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: 2 generations back to K963759 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012406: Access Sequestration System, Interpore Cross Intl. (2002)
- K011148: Ultraconcentrator System, Interpore Cross Intl. (2001)

## Indications for use
The Interpore Cross International AccessTM 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/K022348
Methodology: https://510kreport.com/methodology