# K961137: Ati Plasma Pump (PP-04)

- Pathway: 510(k) (Traditional)
- Applicant: Apheresis Technologies, Inc.
- Decided: Jun 14, 1996 after 85 days
- Product code: FIR (Pump, Blood, Extra-Luminal)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jul 9, 2012 · Class II · Z-2149-2012: On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma
- Apr 1, 2009 · Not classified · Z-1897-2009: Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading 

Source page: https://510kreport.com/device/K961137
Methodology: https://510kreport.com/methodology